NCT00015912

Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of combining thalidomide with interferon alfa in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of cancer cells. Combining thalidomide with interferon alfa may kill more tumor cells

Detailed description

PRIMARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon alfa	Given IV
DRUG	thalidomide	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2001-07-01
• Primary completion: 2003-09-01
• First posted: 2003-10-15
• Last updated: 2013-01-25

Locations

1 site across 1 country: United States