Clinical Trials Directory

Trials / Completed

CompletedNCT00132015

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis

A Phase II Clinical Trial of 17-(Allylamino)-17- Demethoxygeldanamycin (17-AAG, NSC 330507 and EPL Diluent, NSC 704057) in Adults With Systemic Mastocytosis

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
37 (estimated)
Sponsor
National Institutes of Health Clinical Center (CC) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

Interventions

TypeNameDescription
DRUGtanespimycin

Timeline

Start date
2006-05-01
Primary completion
2007-12-01
Completion
2008-06-01
First posted
2005-08-19
Last updated
2012-03-15

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00132015. Inclusion in this directory is not an endorsement.