Geldanamycin Analogue in Treating Patients With Advanced Cancer
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 a geldanamycin analogue in treating patients with advanced cancer.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies|
- Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks [ Designated as safety issue: Yes ]
- Heat shock protein 90 (HSP90) client protein and co-chaperone changes during first course of treatment [ Designated as safety issue: No ]
- Pharmacokinetic profile of 17-AAG during the first course of treatment [ Designated as safety issue: No ]
|Study Start Date:||August 1998|
|Study Completion Date:||January 2007|
- Determine the maximum tolerated dose for a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies.
- Determine the toxic effects and dose-limiting toxicity of AAG in this patient population.
- Determine the safe dose of AAG for a Phase II study.
- Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients.
- Assess time to tumor progression and any antitumor activity in patients treated with AAG.
OUTLINE: This is a dose-escalation study.
Patients receive a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), IV over 15-30 minutes every week. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003969
|Royal Marsden NHS Foundation Trust - London|
|London, England, United Kingdom, SW3 6JJ|
|Study Chair:||Ian R. Judson, MA, MD, FRCP||Royal Marsden NHS Foundation Trust|