Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00015912 |
Recruitment Status :
Terminated
(Administratively complete.)
First Posted : October 15, 2003
Last Update Posted : January 25, 2013
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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 |
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 (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 |
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.
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Biological: recombinant interferon alfa
Given IV
Other Names:
Drug: thalidomide Given orally
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- Response rate (complete and partial) [ Time Frame: Up to 2 years ]
- Time to progression [ Time Frame: Up to 2 years ]Kaplan-Meier estimates will be determined.
- Overall survival [ Time Frame: Up to 2 years ]Kaplan-Meier estimates will be determined.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80217-3364 |
Principal Investigator: | John Sweetenham | University of Colorado, Denver |
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 |
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 |