Alkylator-Intense Conditioning Followed by Autologous Transplantation for Patients With High Risk or Relapsed Solid or CNS Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood stem cell transplant will be given for 3 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have histological verification of malignancy at original diagnosis.
- •Eligible Diseases
- •Arm A: Solid Tumor
- •Ewing's Family Tumors (ES/PNET/DSRCT) - metastatic at time of diagnosis and/or relapsed after therapy
- •Renal Tumors - relapsed (all histology - Wilm's tumor) or at diagnosis (clear cell sarcoma and Rhabdoid tumor)
- •Hepatoblastoma - metastatic at time of diagnosis and/or relapsed after therapy
- •Rhabdomyosarcoma - metastatic at time of diagnosis and/or relapsed after therapy
- •Soft Tissue Sarcoma - chemotherapy responsive metastatic disease or chemotherapy responsive relapsed disease
- •Primary Malignant Brain Neoplasms <18 years of age - at diagnosis and/or relapse
- •Retinoblastoma - disseminated at diagnosis and/or relapsed
- •CNS Lymphoma - primary or secondary CNS lymphoma.
- •Other High Risk Metastatic or Relapsed Solid Tumors - to be approved by 2 or more pediatric hematology/oncology and bone marrow transplant (BMT) physicians
- •Arm B: Certain CNS tumors
- •Medulloblastoma: Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) who have high risk Medulloblastoma, defined as any one of the following:
- •> 1.5 cm2 residual disease following resection for any Medulloblastoma histology
- •lumbar CSF cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or at least 10 days after definitive surgery
- •MRI evidence of (a) gross nodular seeding in the intracranial subarachnoid space or ventricular system distant from primary tumor site, M2; or (b) gross nodular seeding in the spinal subarachnoid space +/- evidence of intracranial seeding, M3; or (c) extraneural metastases, M4,
- •Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age, any metastatic stage, with total or sub-total resection.
- •Infant Medulloblastoma: Children less than 8 months of age at the time of definitive surgery (for histopathologic diagnosis), any histology, any metastatic state, with total or sub-total resection.
- •Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) with or without metastatic disease
- •Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS AT/RT (with or without metastatic disease).
- •Other High Risk CNS Tumors - to be approved by 2 or more physicians (at least one oncologist and one BMT physician).
- •Arm C: Germ Cell Tumors
- •Confirmation of germ cell tumor (GCT) histology (both seminoma and nonseminoma). Tumor may have originated in any primary site. NOTE: In rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established. This would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG ≥ 500; AFP ≥ 500} and typical pattern of metastases).
- •One or more unfavorable prognostic features for achieving a CR with conventional-dose chemotherapy. Unfavorable prognostic features include:
- •extragonadal primary site
- •PD following an incomplete response (IR) to first-line therapy,
- •PD after a conventional-dose salvage (cisplatin + ifosfamide -based) regimen
- •Arm D: Certain CNS Tumor patients who can only undergo one transplant
- •Medulloblastoma: Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) who have high risk Medulloblastoma, defined as any one of the following:
- •> 1.5 cm2 residual disease following resection for any Medulloblastoma histology
- •lumbar CSF cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or at least 10 days after definitive surgery
- •MRI evidence of (a) gross nodular seeding in the intracranial subarachnoid space or ventricular system distant from primary tumor site, M2; or (b) gross nodular seeding in the spinal subarachnoid space +/- evidence of intracranial seeding, M3; or (c) extraneural metastases, M4,
- •Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age, any metastatic stage, with total or sub-total resection.
- •Infant Medulloblastoma: Children less than 8 months of age at the time of definitive surgery (for histopathologic diagnosis), any histology, any metastatic state, with total or sub-total resection.
- •Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than 36 months (3 years) of age at time of definitive surgery (for histopathologic diagnosis) with or without metastatic disease
- •Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS AT/RT (with or without metastatic disease).
- •Other High Risk CNS Tumors including choroid plexus carcinoma in children- to be approved by 2 or more physicians (at least one oncologist and one BMT physician).
- •Arm E: Neuroblastoma ** Neuroblastoma (ICD-O morphology 9500/3) or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
- •Disease Status at Enrollment
- •Arm A, Arm B and Arm D must have fit one of the following:
- •no evidence of disease or
- •stable, non-progressive disease (defined as non-progressive abnormalities on physical exam or CT and/or MRI) within 4 weeks of study entry
- •Arm C: Evidence of progressive or recurrent GCT (measurable or non-measurable) following one or more cisplatin-based chemotherapy, defined as meeting at least one of the following criteria:
- •Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT. Patients with incomplete gross resection where viable GCT is found are considered eligible.
- •Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease.
- •Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.
- •Arm E: Patients with the following disease stages at diagnosis are eligible, if they meet the other specified criteria.
- •Patients with newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following:
- •MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or
- 另有 59 项未显示
排除标准
- •Arm A, B, C, and D:
- •Pregnant or breastfeeding
- •Active, uncontrolled infection and/or human immunodeficiency virus (HIV) positive constitute progressive disease.
- •Concomitant enrollment on clinical study (such as COG study) that does not allow co-enrollment on this standard of care protocol (Arm B only)
- •Arm E: Pregnant or breastfeeding
- •Active, uncontrolled infection and/or HIV positive
- •Known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than that determined to be feasible at the collecting institution, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.
- •Patients that are 12-18 months of age with INSS Stage 4 and all 3 favorable biologic features (ie, non- amplified MYCN, favorable pathology, and DNA index > 1).
研究组 & 干预措施
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Ifosfamide (Drug)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Etoposide (Drug)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Mesna (Drug)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: G-CSF (Biological)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Busulfan (Drug)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Melphalan (Drug)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Thiotepa (Drug)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Autologous stem cell infusion (Biological)
Arm A: Patients with High Risk or Relapsed Solid Tumor
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.
干预措施: Radiation (Radiation)
Arm B: Certain CNS Tumors
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
干预措施: Ifosfamide (Drug)
Arm B: Certain CNS Tumors
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
干预措施: Etoposide (Drug)
Arm B: Certain CNS Tumors
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
干预措施: Mesna (Drug)
Arm B: Certain CNS Tumors
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
干预措施: G-CSF (Biological)
Arm B: Certain CNS Tumors
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
干预措施: Thiotepa (Drug)
Arm B: Certain CNS Tumors
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
干预措施: Autologous stem cell infusion (Biological)
Arm B: Certain CNS Tumors
Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, carboplatin (dose based on GFR and age 17 mg/kg/day IV or 510 mg/m^2/day IV) , thiotepa conditioning (10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0). This will be repeated up to 2 additional 30 day cycles.
干预措施: Carboplatin (Drug)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: Ifosfamide (Drug)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: Etoposide (Drug)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: Mesna (Drug)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: G-CSF (Biological)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: Autologous stem cell infusion (Biological)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: Carboplatin (Drug)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: Paclitaxel (Drug)
Arm C: Germ Cell Tumors
- High-Dose Chemotherapy (3 cycles)
- Carboplatin AUC=8 & Etoposide 400 mg/m^2 daily, days -4, -3, and -2 every 21 days
- Autologous Stem Cell Infusion ≥ 3 x 106 CD34+ cells/kg Day 0 Cycles 1, 2 and 3
- TI Chemotherapy & PBSC Collection.
- Paclitaxel 200mg/m^2 IV over 3 hours on Day 1 every 14 days for 2 cycles
- Ifosfamide 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles
- Mesna 2000 mg/m^2 on Days 1-3 every 14 days for 2 cycles
- G-CSF 10 μg/kg sub q daily on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first
- Leukapheresis starting on approx. day 11 and continued daily until reaching the collection goal of ≥ 8 x 106 CD34+ cells/kg) or day 15, whichever occurs first
干预措施: Leukapheresis (Procedure)
Arm D: Certain CNS Tumors
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (3 cycles)
- Day -8, -7, -6: Carboplatin as calculated from AUC of 7 approx.
- Day -5, -4, -3: Thiotepa 10 mg/kg, Etoposide 8.3 mg/kg
- Day 0: Autologous Hematopoietic Cell Reinfusion
- Day +1: Begin G-CSF(filgrastim) 5 mcg/kg
干预措施: Etoposide (Drug)
Arm D: Certain CNS Tumors
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (3 cycles)
- Day -8, -7, -6: Carboplatin as calculated from AUC of 7 approx.
- Day -5, -4, -3: Thiotepa 10 mg/kg, Etoposide 8.3 mg/kg
- Day 0: Autologous Hematopoietic Cell Reinfusion
- Day +1: Begin G-CSF(filgrastim) 5 mcg/kg
干预措施: G-CSF (Biological)
Arm D: Certain CNS Tumors
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (3 cycles)
- Day -8, -7, -6: Carboplatin as calculated from AUC of 7 approx.
- Day -5, -4, -3: Thiotepa 10 mg/kg, Etoposide 8.3 mg/kg
- Day 0: Autologous Hematopoietic Cell Reinfusion
- Day +1: Begin G-CSF(filgrastim) 5 mcg/kg
干预措施: Thiotepa (Drug)
Arm D: Certain CNS Tumors
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (3 cycles)
- Day -8, -7, -6: Carboplatin as calculated from AUC of 7 approx.
- Day -5, -4, -3: Thiotepa 10 mg/kg, Etoposide 8.3 mg/kg
- Day 0: Autologous Hematopoietic Cell Reinfusion
- Day +1: Begin G-CSF(filgrastim) 5 mcg/kg
干预措施: Autologous stem cell infusion (Biological)
Arm D: Certain CNS Tumors
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (3 cycles)
- Day -8, -7, -6: Carboplatin as calculated from AUC of 7 approx.
- Day -5, -4, -3: Thiotepa 10 mg/kg, Etoposide 8.3 mg/kg
- Day 0: Autologous Hematopoietic Cell Reinfusion
- Day +1: Begin G-CSF(filgrastim) 5 mcg/kg
干预措施: Carboplatin (Drug)
Arm E: Neuroblastoma
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (day -7 to day -0)
- Day -7: anti-seizure prophylaxis with lorazepam or levetiracetam
- Day -6 - -3: Busulfan IV q24 hours x 4 doses
- Day -1: Melphalan 140 mg/m2 IV
- Day 0: Autologous Hematopoietic Cell Reinfusion
干预措施: G-CSF (Biological)
Arm E: Neuroblastoma
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (day -7 to day -0)
- Day -7: anti-seizure prophylaxis with lorazepam or levetiracetam
- Day -6 - -3: Busulfan IV q24 hours x 4 doses
- Day -1: Melphalan 140 mg/m2 IV
- Day 0: Autologous Hematopoietic Cell Reinfusion
干预措施: Busulfan (Drug)
Arm E: Neuroblastoma
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (day -7 to day -0)
- Day -7: anti-seizure prophylaxis with lorazepam or levetiracetam
- Day -6 - -3: Busulfan IV q24 hours x 4 doses
- Day -1: Melphalan 140 mg/m2 IV
- Day 0: Autologous Hematopoietic Cell Reinfusion
干预措施: Melphalan (Drug)
Arm E: Neuroblastoma
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (day -7 to day -0)
- Day -7: anti-seizure prophylaxis with lorazepam or levetiracetam
- Day -6 - -3: Busulfan IV q24 hours x 4 doses
- Day -1: Melphalan 140 mg/m2 IV
- Day 0: Autologous Hematopoietic Cell Reinfusion
干预措施: Autologous stem cell infusion (Biological)
Arm E: Neuroblastoma
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (day -7 to day -0)
- Day -7: anti-seizure prophylaxis with lorazepam or levetiracetam
- Day -6 - -3: Busulfan IV q24 hours x 4 doses
- Day -1: Melphalan 140 mg/m2 IV
- Day 0: Autologous Hematopoietic Cell Reinfusion
干预措施: Anti-seizure prophylaxis (Drug)
Arm E: Neuroblastoma
- Mobilization Chemotherapy and PBSC Collection (day -100 to day -30)
- Pre-Transplant Conditioning Chemotherapy (day -7 to day -0)
- Day -7: anti-seizure prophylaxis with lorazepam or levetiracetam
- Day -6 - -3: Busulfan IV q24 hours x 4 doses
- Day -1: Melphalan 140 mg/m2 IV
- Day 0: Autologous Hematopoietic Cell Reinfusion
干预措施: Ursodiol (Drug)
结局指标
主要结局
Overall Survival
时间窗: 1 Year
Number of patients who have received autologous transplant for high risk or relapsed solid tumor and certain CNS tumors and are alive at 1 year.
次要结局
- Number of Patients Who Achieved Transplant Engraftment(Day 42)
- Disease Free Survival(3 Years)
- Treatment-Related Mortality(Day 100)