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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

Phase 2
18 Years
Not Enrolling
Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma

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Trial Information

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


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

III. Correlate ancillary biological studies with clinical endpoints in these patients
treated with this regimen.


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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate (complete and partial)

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

John Sweetenham

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Food and Drug Administration

Study ID:




Start Date:

July 2001

Completion Date:

Related Keywords:

  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



University of Colorado Denver, Colorado  80217