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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Drug: thalidomide
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed relapsed or refractory low-grade follicular non-Hodgkin's lymphoma (NHL) WHO grade 1 or 2 Failure to achieve a complete or partial remission after prior treatment regimen Relapse or disease progression within 30 days after prior treatment regimen No histologic transformation to aggressive NHL or areas of diffuse NHL At least 1 measurable lesion by CT scan, MRI, or chest x-ray Tissue in the form of tissue blocks available No brain metastasis or primary brain tumors Performance status - ECOG 0-1 More than 3 months Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8.5 g/dL Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal PT (or INR)/PTT normal or not clinically significant No preexisting liver disease Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 60 mL/min No uncompensated coronary artery disease No myocardial infarction or severe/unstable angina within the past 6 months No active infection No prior gastrointestinal disorder that would interfere with thalidomide absorption No preexisting autoimmune disease No medical, psychological, or social problem that would preclude study participation No uncontrolled or untreated depression No emotional disorder or substance abuse No prior seizures or potential risk factors for development of seizures HIV negative Not pregnant or nursing Negative pregnancy test at baseline, weekly for 4 weeks, and then every 2-4 weeks thereafter while on study Fertile female patients must use 1 highly active method and 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study Fertile male patients must use effective barrier contraception during and for 4 weeks after study participation No more than 1 prior course of unconjugated monoclonal antibody therapy No prior conjugated monoclonal antibody (radiolabeled or immunotoxin) therapy No prior interferon alfa No concurrent hematopoietic growth factors or other cytokines No concurrent monoclonal antibodies No more than 2 prior chemotherapy regimens (single agent or combination) At least 28 days since prior chemotherapy No concurrent chemotherapy At least 28 days since prior corticosteroid therapy Prior or concurrent megestrol allowed No concurrent corticosteroids No concurrent hormonal therapy Prior palliative radiotherapy to nontarget lesions allowed No prior radiotherapy to all sites of measurable disease No prior extensive radiotherapy to more than 20% of bone marrow No concurrent palliative radiotherapy At least 14 days since prior major surgery No prior major upper gastrointestinal surgery No other concurrent cytotoxic agents No other concurrent investigational therapy No other concurrent anticancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (interferon-alpha, thalidomide)<br>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<br>* Given IV<br>* Other names: Roferon-A;Drug: thalidomide<br>* Given orally<br>* Other names: Thalomid;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (complete and partial) |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Kaplan-Meier estimates will be determined. | Up to 2 years | 
| Overall survival | Kaplan-Meier estimates will be determined. | Up to 2 years |