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

January 24, 2013 updated by: National Cancer Institute (NCI)

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80217-3364
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
Other: laboratory biomarker analysis
Correlative studies
Drug: thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
Biological: recombinant interferon alfa
Given IV
Other Names:
  • Roferon-A
  • Intron A
  • alpha interferon
  • IFN-A
  • Alferon N

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate (complete and partial)
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: John Sweetenham, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (ACTUAL)

September 1, 2003

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

October 14, 2003

First Posted (ESTIMATE)

October 15, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02379
  • 00-171; CWRU 5Y99
  • CDR0000068572 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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