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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
N/A
Not Enrolling
Both
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


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.


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

Type of Study:

Interventional

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:

No

Principal Investigator

John Sweetenham

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02379

NCT ID:

NCT00015912

Start Date:

July 2001

Completion Date:

Related Keywords:

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

Name

Location

University of ColoradoDenver, Colorado  80217