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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00117988 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: 17-AAG (Tanespimycin) |
Phase II |
| Study Type: | Interventional |
| 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) |
| Enrollment: | 22 |
| Study Start Date: | February 2005 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 17-AAG
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
|
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Anas Younes, M.D., M. D. Anderson Cancer Center at University of Texas |
| ClinicalTrials.gov Identifier: | NCT00117988 History of Changes |
| Other Study ID Numbers: | 2004-0792, P30CA016672, MDA-2004-0792, NCI-6936, CDR0000433593 |
| Study First Received: | July 8, 2005 |
| Results First Received: | May 5, 2011 |
| Last Updated: | May 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
anaplastic large cell lymphoma recurrent adult Hodgkin lymphoma recurrent mantle cell lymphoma 17-N-allylamino-17-demethoxygeldanamycin 17-AAGCD30+ Anaplastic Large Cell Lymphoma ALCL |
Classical Hodgkin's Lymphoma HL heat shock protein HSP HSP90 Tanespimycin |
|
Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Mantle-Cell Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, T-Cell |