Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of 17-AAG in Patients With Relapsed/Refractory CD30+ Anaplastic Large Cell Lymphoma (ALCL), Relapsed/Refractory Mantle Cell Lymphoma (MCL), and Relapsed/Refractory Classical Hodgkin's Lymphoma (HL)
This phase II trial is studying how well 17-AAG works in treating patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVE:
I. Determine the complete and partial response rates and time to treatment failure in
patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma,
or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin
(17-AAG).
SECONDARY OBJECTIVES:
I. Determine the safety of this drug in these patients. II. Determine the biologic effect of
this drug on selected molecular targets in primary lymphoma cells from these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type
(anaplastic large cell lymphoma vs mantle cell lymphoma vs Hodgkin's lymphoma).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1,
4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Patients experiencing disease regression after
completion of 8 courses may receive 2 additional courses of treatment beyond their maximal
response.
After completion of study treatment, patients are followed every 3 months until disease
progression.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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