17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in Treating Patients With an Advanced Solid Tumor or Lymphoma
|ClinicalTrials.gov Identifier: NCT00088868|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : March 15, 2012
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with an advanced solid tumor or lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: alvespimycin hydrochloride||Phase 1|
- Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with an advanced malignant solid tumor or lymphoma.
- Determine the dose-limiting toxic effects and toxicity profile of this drug in these patients.
- Compare the effects of this drug on heat shock protein 90 (Hsp90) client proteins when assayed in peripheral blood mononuclear cells (PBMC) vs tumor tissue from patients treated with this drug.
- Correlate disturbances in key signaling pathways with administration of this drug in these patients.
- Determine the dose that alters key proteins in the majority of patients treated with this drug.
- Correlate serum proteomic patterns with target interactions or DMAG clinical effects in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a single-center, dose-escalation study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-2 hour on days 1 and 4 or days 2 and 5 weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of 17-DMAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at the MTD.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||A Phase I Study Of 17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17DMAG) With Evaluation Of Hsp90 Client Proteins In Subjects With Solid Tumors And Lymphomas|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||December 2010|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088868
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Shivaani Kummar, MD||NCI - Medical Oncology Branch|