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

NCT ID: NCT00015912

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

Given IV

thalidomide

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

recombinant interferon alfa

Given IV

Intervention Type: BIOLOGICAL

thalidomide

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Alferon N; alpha interferon; IFN-A; Intron A; Roferon-A; Kevadon; Synovir; THAL; Thalomid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Sweetenham

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Denver, Colorado, United States

Countries

United States

Other Identifiers

00-171; CWRU 5Y99

Identifier Type: -

Identifier Source: secondary_id

CDR0000068572

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02379

Identifier Type: -

Identifier Source: org_study_id