Clinical Trial: Interferon alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the growth of non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of interferon alfa-2b in treating patients who have advanced low-grade non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
stage III grade II follicular mixed cell lymphoma
stage IV grade II follicular mixed cell lymphoma
contiguous stage II diffuse small lymphocytic/marginal zone lymphoma
noncontiguous stage II grade II follicular mixed cell lymphoma
noncontiguous stage II grade I follicular small cleaved cell lymphoma
noncontiguous stage II diffuse small lymphocytic/marginal zone lymphoma
stage III grade I follicular small cleaved cell lymphoma
stage IV diffuse small lymphocytic/marginal zone lymphoma
contiguous stage II grade II follicular mixed cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
stage IV grade I follicular small cleaved cell lymphoma
stage III diffuse small lymphocytic/marginal zone lymphoma
contiguous stage II grade I follicular small cleaved cell lymphoma
 Drug: pegylated interferon alfa
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Pegylated Interferon alfa-2b in Patients With Minimally Treated or Previously Untreated Advanced Low Grade Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: December 1999

OBJECTIVES: I. Determine the response to pegylated interferon alfa-2b in patients with minimally treated or previously untreated advanced low grade non-Hodgkin's lymphoma. II. Determine the effects of this treatment regimen on the immune system by measuring T-cell subsets and NK cells in this patient population. III. Determine event free survival and progression free survival in this patient population treated with this regimen. IV. Evaluate the toxicity profile of this treatment regimen in these patients.

PROTOCOL OUTLINE: Patients receive pegylated interferon alfa-2b subcutaneously once weekly for 6 months in the absence of disease progression or unacceptable toxicity. Upon completion of treatment, patients are followed every 6 months for at least 2 years.

PROJECTED ACCRUAL: A total of 30 patients will be initially accrued for this study. Additional patients will be accrued if acceptable responses are seen in the first cohort.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

--Prior/Concurrent Therapy--

  • Biologic therapy: See Disease Characteristics; At least 12 weeks since prior immunotherapy (e.g., rituximab); No prior cytokines (except filgrastim (G-CSF) or epoetin alfa)
  • Chemotherapy: See Disease Characteristics
  • Endocrine therapy: No concurrent systemic corticosteroids
  • Radiotherapy: See Disease Characteristics
  • Surgery: Not specified

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Karnofsky 70-100%
  • Life expectancy: Not specified
  • Hematopoietic: WBC greater than 2,000/mm3; Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 75,000/mm3; Hemoglobin greater than 10 g/dL; Absolute lymphocyte count no greater than 5,000/mm3
  • Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); SGOT/SGPT less than 2.5 times ULN; Alkaline phosphatase less than 2.5 times ULN; No active hepatitis
  • Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min
  • Cardiovascular: No severe cardiovascular disease; No myocardial infarction within the past 6 months; No unstable angina; No class III or IV congestive heart failure; No ventricular tachyarrhythmias
  • Other: No active uncontrolled infections or infections requiring systemic antibiotics; HIV negative; No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix; No history of neuropsychiatric disorder requiring hospitalization; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Carol S. Portlock,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068054; MSKCC-99101; NCI-G00-1814
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00006039
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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