17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG) in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: alvespimycin hydrochloride
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Cancer Research UK Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of 17-Dimethylaminoethyl-amino-17-Demethoxygeldanamycin (17-DMAG) Given as a Once Weekly Infusion in Patients With Advanced Solid Tumors|
- Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment
- Heat shock protein 90 (HSP90) client protein and co-chaperone changes up to 29 days after treatment
- Tumor response by RECIST criteria every 6 weeks while on study
- Clinical pharmacokinetic profile established during the first course of treatment
|Study Start Date:||October 2005|
|Estimated Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with unresectable or metastatic solid tumors.
- Determine the feasibility, safety, and toxicity profile of this drug in these patients.
- Determine the clinical pharmacokinetic profile of this drug in these patients.
- Determine tumor response in patients treated with this drug.
- Determine the biologically effective dose.
OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 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 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed for 28 days.
PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study within 12-18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248521
|Institute of Cancer Research - Sutton|
|Sutton, England, United Kingdom, SM2 5NG|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Belfast City Hospital Trust Incorporating Belvoir Park Hospital|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Study Chair:||Ian R. Judson, MA, MD, FRCP||Institute of Cancer Research, United Kingdom|