Lymphoma Clinical Trial
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
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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