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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00015912
First received: May 6, 2001
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Biological: recombinant interferon alfa
Drug: thalidomide
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete and partial) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be determined.

  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be determined.


Enrollment: 35
Study Start Date: July 2001
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015912

Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80217-3364
Sponsors and Collaborators
Investigators
Principal Investigator: John Sweetenham University of Colorado, Denver
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00015912     History of Changes
Other Study ID Numbers: NCI-2012-02379, 00-171; CWRU 5Y99, CDR0000068572
Study First Received: May 6, 2001
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Interferons
Thalidomide
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014