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

Recurrent Grade 1 Follicular Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00015912
• Other study ID #: NCI-2012-02379
• Secondary ID: 00-171; CWRU 5Y9
• Status: Terminated
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: January 24, 2013
• Start date: July 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma

Intervention

Biological:
• recombinant interferon alfa
Given IV

Drug:
• thalidomide
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Colorado	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (complete and partial)		Up to 2 years	No
Secondary	Time to progression	Kaplan-Meier estimates will be determined.	Up to 2 years	No
Secondary	Overall survival	Kaplan-Meier estimates will be determined.	Up to 2 years	No