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Interferon Alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma, Small Intestine Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegylated interferon alfa
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring small intestine lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed low-grade lymphoma including any of the following: REAL classification Follicular lymphoma (grade I or II) Lymphoplasmacytoid lymphoma Small lymphocytic lymphoma Marginal B-cell lymphoma MALT lymphoma International Working Formulation Follicular small cleaved cell lymphoma Follicular mixed small and large cell lymphoma Small lymphocytic lymphoma No intermediate or high-grade non-Hodgkin's lymphoma (NHL) histology No evidence of histologic transformation If previously untreated, large tumor burden including any of the following: Nodal or extranodal mass greater than 7 cm in diameter Involvement of at least 3 nodal sites (each greater than 3 cm in diameter) Systemic symptoms Splenomegaly Ureteral compression Intraabdominal stage II, stage III, or stage IV disease Measurable disease No prior systemic therapy OR No more than 1 prior therapy ( e.g., chemotherapy, immunotherapy, chemotherapy with immunotherapy, or chemotherapy with regional radiotherapy) 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. 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 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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006039
Brief Title
Interferon Alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma
Official Title
Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B (PEGIntron) in Advanced Stage Low Grade Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
March 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: I. Determine the response in patients with minimally treated or previously untreated advanced low-grade non-Hodgkin's lymphoma treated with pegylated interferon alfa-2b. 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 and progression-free survival in this patient population treated with this regimen. IV. Evaluate the toxicity profile of this treatment regimen in these patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Small Intestine Cancer
Keywords
small intestine lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
pegylated interferon alfa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed low-grade lymphoma including any of the following: REAL classification Follicular lymphoma (grade I or II) Lymphoplasmacytoid lymphoma Small lymphocytic lymphoma Marginal B-cell lymphoma MALT lymphoma International Working Formulation Follicular small cleaved cell lymphoma Follicular mixed small and large cell lymphoma Small lymphocytic lymphoma No intermediate or high-grade non-Hodgkin's lymphoma (NHL) histology No evidence of histologic transformation If previously untreated, large tumor burden including any of the following: Nodal or extranodal mass greater than 7 cm in diameter Involvement of at least 3 nodal sites (each greater than 3 cm in diameter) Systemic symptoms Splenomegaly Ureteral compression Intraabdominal stage II, stage III, or stage IV disease Measurable disease No prior systemic therapy OR No more than 1 prior therapy ( e.g., chemotherapy, immunotherapy, chemotherapy with immunotherapy, or chemotherapy with regional radiotherapy) 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. 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol S. Portlock, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Interferon Alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma

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