17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00117988|
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 30, 2011
Last Update Posted : May 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Mantle Cell Lymphoma||Drug: tanespimycin||Phase 2|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Arm I
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.
Other Name: 17-AAG
- Number of Patients With Response [ Time Frame: Baseline to time to best response; Every 6 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117988
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anas Younes||M.D. Anderson Cancer Center|