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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00015912

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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

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

Detailed Description

PRIMARY OBJECTIVES:

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.
Determine the quantitative and qualitative toxic effects of this regimen in this patient population.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jul 1, 2001

Actual Primary Completion Date :

Sep 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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 Given IV Other Names: Alferon N alpha interferon IFN-A Intron A Roferon-A Drug: thalidomide Given orally Other Names: Kevadon Synovir THAL Thalomid Other: laboratory biomarker analysis Correlative studies

Arm

Intervention/Treatment

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

Given IV

Other Names:

Alferon N

alpha interferon

IFN-A

Intron A

Roferon-A

Drug: thalidomide

Given orally

Other Names:

Kevadon

Synovir

THAL

Thalomid

Other: laboratory biomarker analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Response rate (complete and partial) [Up to 2 years]

Secondary Outcome Measures

Time to progression [Up to 2 years]
Kaplan-Meier estimates will be determined.
Overall survival [Up to 2 years]
Kaplan-Meier estimates will be determined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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