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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00015912
Recruitment Status : Terminated (Administratively complete.)
First Posted : October 15, 2003
Last Update Posted : January 25, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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:

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 Design
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Study Type : Interventional  (Clinical Trial)
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 : July 2001
Actual Primary Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Response rate (complete and partial) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Up to 2 years ]
    Kaplan-Meier estimates will be determined.

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015912


Locations
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United States, Colorado
University of Colorado
Denver, Colorado, United States, 80217-3364
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John Sweetenham University of Colorado, Denver
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00015912    
Other Study ID Numbers: NCI-2012-02379
00-171; CWRU 5Y99
CDR0000068572 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 15, 2003    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Interferons
Interferon-alpha
Interferon alpha-2
Thalidomide
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors