17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
RATIONALE: 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.
PURPOSE: 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of 17 -AAG in Patients With RelapsedRefractory CD30 + Anaplastic Large Cell Lymphoma (ALCL) Relapsed/Refractory Mantle Cell Lymphoma (MCL) and Relapsed/Refractory Classical Hodgkin's Lymphoma (HL)|
- Number of Patients With Response [ Time Frame: Baseline to time to best response; Every 6 weeks ] [ Designated as safety issue: No ]Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses.
|Study Start Date:||February 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
Drug: 17-AAG (Tanespimycin)
220 mg/m^2 infused intravenously over two hours (but may be extended up to a max of 6 hrs) on days 1, 4, 8, and 11 of a 21 (+ 2 days) day-cycle.
Other Name: 17-N-allylamino-17-demethoxygeldanamycin
- 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).
- Determine the safety of this drug in these patients.
- 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.
PROJECTED ACCRUAL: A total of 36-105 patients (12-35 per stratum) will be accrued for this study within 2 years.
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Anas Younes, MD||M.D. Anderson Cancer Center|