NCT00262886已完成2 期
Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Response rate based on tumor measurements at 1 year
研究概览
简要总结
RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer.
PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a pilot study.
- Conditioning regimen: Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -1. Patients receiving 5/6-mismatched cells also receive anti-thymocyte globulin IV on days -5 to -3.
- Allogeneic peripheral blood stem cell (PBSC) infusion: Patients undergo allogeneic PBSC or bone marrow transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral mycophenolate mofetil twice daily on days 0-30. Patients receive tacrolimus IV continuously or orally twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD.
- Donor lymphocyte infusion: Patients with partial or complete T-cell chimerism receive up to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease.
After completion of study treatment, patients are evaluated periodically for 3 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic renal cell carcinoma
- •Relapsed or refractory disease
- •Tumor not amenable to complete surgical resection
- •No bone metastases only
- •No untreated brain metastases
- •Measurable disease
- •Available sibling donor who is HLA-identical or who has a mismatch at a single HLA locus (i.e., a 6/6 or 5/6 match at the HLA-A, -B, and -DR loci)
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin < 3 mg/dL
- •Creatinine < 2 mg/dL
- •No untreated hypercalcemia
- •Cardiovascular
- •LVEF ≥ 40%
- •DLCO ≥ 40%
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •HIV-1 and -2 negative
- •No uncontrolled infection
- •No other active malignancy except basal skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •At least 15 days since prior treatment for renal cell carcinoma
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Response rate based on tumor measurements at 1 year
次要结局
- Toxicity as measured by NCI CTC at days 0, 7, 14, 21 and 28 after transplantation and monthly for 11 months
- Overall and disease-free survival at day 100 and 1 year after transplantation
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Nonmyeloablative Allogeneic TransplantParoxysmal Nocturnal HemoglobinuriaAcute Myelogenous LeukemiaAcute Lymphocytic LeukemiaHodgkin's LymphomaNon-Hodgkin's LymphomaWaldenstrom MacroglobulinemiaBreast CancerMultiple MyelomaOvarian CancerMelanomaChronic Lymphocytic LeukemiaSarcomaRenal Cell CarcinomaMyelodysplastic SyndromeAplastic AnemiaChronic Myelogenous LeukemiaMantle Cell LymphomaThymomaNCT01272817Scripps Health36
招募中
2 期
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cellsMDS (Myelodysplastic Syndrome)Severe Aplastic AnemiaNCT01174108National Heart, Lung, and Blood Institute (NHLBI)120
Unknown
2 期
Hematopoietic Stem Cell Transplantation in MyelomaMultiple MyelomaNCT00415987Azienda Ospedaliera San Giovanni Battista
终止
2 期
Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic CancerChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmLymphomaLeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsUnusual Cancers of ChildhoodNCT00281879OHSU Knight Cancer Institute200
已完成
1 期
Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous DiseaseKidney CancerMyelodysplastic SyndromesLymphomaLeukemiaSarcomaNeuroblastomaNCT00118326Fred Hutchinson Cancer Center