A Phase I Study Of 17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17DMAG) With Evaluation Of Hsp90 Client Proteins In Subjects With Solid Tumors And Lymphomas
- 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
- 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
- Determine the dose that alters key proteins in the majority of patients treated with
- 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.
Primary Purpose: Treatment
Shivaani Kummar, MD
NCI - Medical Oncology Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|