17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), 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 II trial is studying how well 17-AAG works in treating patients with systemic mastocytosis.
Chronic Myeloproliferative Disorders
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial of 17-(Allylamino)-17- Demethoxygeldanamycin (17-AAG, NSC 330507 and EPL Diluent, NSC 704057) in Adults With Systemic Mastocytosis|
- Objective response (complete and partial response) [ Designated as safety issue: No ]
- Quality of life as assessed by the European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at baseline and prior to each treatment course [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), in terms of decreases in the number of mast cells in the bone marrow and in serum tryptase levels, in patients with systemic mastocytosis.
- Determine the quality of life of patients treated with this drug.
- Determine hematological and non-hematological toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients achieving a partial response receive at least 4 additional courses beyond their maximum response. Selected patients may receive additional courses of therapy beyond the protocol guidelines at the discretion of the principal investigator.
Quality of life is assessed at baseline and before each treatment course.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 10-18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132015
|United States, Maryland|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Antonio T. Fojo, MD, PhD||National Cancer Institute (NCI)|