17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG) in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00248521
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment
- Secondary Outcome Measures
Name Time Method Clinical pharmacokinetic profile established during the first course of treatment Tumor response by RECIST criteria every 6 weeks while on study Heat shock protein 90 (HSP90) client protein and co-chaperone changes up to 29 days after treatment
Trial Locations
- Locations (3)
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Institute of Cancer Research - Sutton
🇬🇧Sutton, England, United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom