Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00004065|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Breast Cancer Colorectal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Lung Cancer Melanoma (Skin) Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: tanespimycin||Phase 1|
- 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.
PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||July 1999|
|Primary Completion Date :||March 2005|
|Study Completion Date :||March 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004065
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Howard I. Scher, MD||Memorial Sloan Kettering Cancer Center|