Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00015912|
Recruitment Status : Terminated (Administratively complete.)
First Posted : October 15, 2003
Last Update Posted : January 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma||Biological: recombinant interferon alfa Drug: thalidomide Other: laboratory biomarker analysis||Phase 2|
I. Determine the efficacy of interferon alfa and thalidomide, in terms of response rate, time to progression, and overall survival, in patients with relapsed or refractory low-grade follicular non-Hodgkin's lymphoma.
II. Determine the quantitative and qualitative toxic effects of this regimen in this patient population.
III. Correlate ancillary biological studies with clinical endpoints in these patients treated with this regimen.
Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months until disease progression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical And Biologic Study Of The Combination Of Low Dose Interferon-Alpha And Thalidomide (NSC #66847) For Patients With Relapsed Or Refractory Low-Grade Follicular Lymphoma|
|Study Start Date :||July 2001|
|Primary Completion Date :||September 2003|
Experimental: Treatment (interferon-alpha, thalidomide)
Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity.
Biological: recombinant interferon alfa
Other Names:Drug: thalidomide
Other Names:Other: laboratory biomarker analysis
- Response rate (complete and partial) [ Time Frame: Up to 2 years ]
- Time to progression [ Time Frame: Up to 2 years ]Kaplan-Meier estimates will be determined.
- Overall survival [ Time Frame: Up to 2 years ]Kaplan-Meier estimates will be determined.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015912
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80217-3364|
|Principal Investigator:||John Sweetenham||University of Colorado, Denver|