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

Primary Purpose

Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
thalidomide
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Grade 1 Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (interferon-alpha, thalidomide)

Arm Description

Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Response rate (complete and partial)

Secondary Outcome Measures

Time to progression
Kaplan-Meier estimates will be determined.
Overall survival
Kaplan-Meier estimates will be determined.

Full Information

First Posted
May 6, 2001
Last Updated
January 24, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00015912
Brief Title
Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
July 2001 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (interferon-alpha, thalidomide)
Arm Type
Experimental
Arm Description
Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Other Intervention Name(s)
Alferon N, alpha interferon, IFN-A, Intron A, Roferon-A
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
thalidomide
Other Intervention Name(s)
Kevadon, Synovir, THAL, Thalomid
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate (complete and partial)
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Time to progression
Description
Kaplan-Meier estimates will be determined.
Time Frame
Up to 2 years
Title
Overall survival
Description
Kaplan-Meier estimates will be determined.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sweetenham
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States

12. IPD Sharing Statement

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

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