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

Stopped early · Phase 2

Conditions studied: Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma

In brief

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

Key facts

Study ID

NCT00015912

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2001-07-01

Last updated by the study team

2013-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Colorado — Denver, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.