NCT00004065已完成1 期
A Phase I Trial of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC #330507) Daily X 5 in Patients With Advanced Cancer Therapeutic Protocol
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with refractory or advanced solid tumors or hematologic malignancies.
- Evaluate the effects of this drug on the expression of signaling proteins present on an individual patient's cancer at the start of treatment and, if possible, post treatment.
OUTLINE: This is a two-phase, dose-escalation, multicenter study. Patients are stratified according to disease (chronic myelogenous leukemia [CML] or Philadelphia chromosome [Ph]+ acute lymphoblastic leukemia [ALL] vs solid tumor).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes twice weekly. Courses repeat every 12 weeks in the absence of disease progression (after at least 2 courses for CML or Ph+ ALL patients) or unacceptable toxicity.
- Accelerated phase: Single patients receive escalating dose levels of 17-AAG until one patient experiences a first course grade 3 or greater toxicity or two different patients experience grade 2 toxicity during any course.
- Standard phase: Cohorts of 3-6 patients in each stratum receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Histologically confirmed advanced primary or malignant solid tumor refractory to standard therapy or for which no curative standard therapy exists
- •Progressive disease evidenced by 1 of the following:
- •Non-prostate cancer (including, but not limited to, breast, ovary, head and neck, non-small cell lung, bladder, kidney, colon, stomach, or malignant melanoma)
- •Development of new lesions or an increase in existing lesions
- •No increase in a biochemical marker (e.g., carcinoembryonic antigen, CA-15-3, or an increase in symptoms) as sole measure of disease
- •Prostate cancer (androgen independent) meeting the following criteria:
- •Progressing metastatic disease on bone scan, CT scan, or MRI
- •Metastatic disease and rising prostate-specific antigen (PSA) values meeting 1 of the following criteria:
- •At least 3 rising PSA values obtained at least 1 week apart = 2 rising values more than 1 month apart with at least 25% increase over the range of values
- •Serum testosterone less than 30 ng/mL
- •Castrate status should be maintained by medical therapies if orchiectomy has not been performed
- •Progressive disease must be evident off antiandrogen therapy if received prior to study entry
- •Registered to protocol MSKCC-9040
- •Cytologically confirmed chronic, accelerated, or blastic phase chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) refractory to standard therapy or for which no curative therapy exists
- •Progressive disease evidenced by 1 of the following:
- •Accelerated or blastic phase disease that is not responsive to standard therapy or loss of hematologic response to imatinib mesylate while remaining in chronic phase for CML
- •Relapsed or refractory after treatment with standard chemotherapy and imatinib mesylate for Ph-positive ALL
- •No active CNS or epidural tumor
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •WBC greater than 3,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •No restrictions based on peripheral blood counts for CML and Ph-positive ALL
- •Bilirubin no greater than 1.2 times upper limit of normal (ULN)
- •AST less than 1.5 times ULN
- •Prothrombin time normal
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •Ejection fraction greater than 45% by radionuclide cardiac angiography
- •No ventricular aneurysm or other abnormal wall motion
- •No reversible defect by thallium stress test if any of the following conditions are present:
- •Ejection fraction less than 45% on radionuclide angiocardiography
- •Worrisome but nonexclusive cardiovascular history
- •Abnormal echocardiogram
- •Patients with the following history or clinical findings require additional diagnostic testing:
- •Significant Q waves (greater than 3 mm or greater than one-third of the height of the QRS complex)
- 另有 38 项未显示
排除标准
- 未提供
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By SurgeryUnspecified Adult Solid Tumor, Protocol SpecificLymphomaNCT00004075Mayo Clinic
已完成
1 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or SarcomaAIDS-related Peripheral/Systemic LymphomaAIDS-related Primary CNS LymphomaAngioimmunoblastic T-cell LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueIntraocular LymphomaMetastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorMetastatic OsteosarcomaNodal Marginal Zone B-cell LymphomaOvarian SarcomaPrimary Central Nervous System Non-Hodgkin LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult Soft Tissue SarcomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaAnaplastic Large Cell LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent OsteosarcomaRecurrent Small Lymphocytic LymphomaRecurrent Uterine SarcomaSmall Intestine LymphomaSplenic Marginal Zone LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Adult Soft Tissue SarcomaStage IV Adult T-cell Leukemia/LymphomaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Mycosis Fungoides/Sezary SyndromeStage IV Small Lymphocytic LymphomaStage IV Uterine SarcomaUnspecified Adult Solid Tumor, Protocol SpecificChondrosarcomaNCT00004241National Cancer Institute (NCI)60
已完成
2 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Kidney CancerKidney CancerNCT00093405Memorial Sloan Kettering Cancer Center
已完成
2 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic MastocytosisChronic Myeloproliferative DisordersNonneoplastic ConditionPrecancerous ConditionLymphomaLeukemiaNCT00132015National Institutes of Health Clinical Center (CC)37
已完成
2 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant MelanomaMelanoma (Skin)NCT00104897Cancer Research UK25