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

This study has been completed.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006039
  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 Intervention Phase
Lymphoma
Small Intestine Cancer
Drug: pegylated interferon alfa
Phase II

MedlinePlus related topics:   Cancer    Intestinal Cancer    Lymphoma   

ChemIDplus related topics:   Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons    Peginterferon Alfa-2b   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B (PEGIntron) in Advanced Stage Low Grade Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006039

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

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Carol S. Portlock, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068054, MSKCC-99101, NCI-G00-1814
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006039
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Interferon Type I, Recombinant
Gastrointestinal Diseases
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Duodenal Neoplasms
Lymphoma, B-Cell
Ileal Neoplasms
Lymphoma
Duodenal Diseases
Jejunal Neoplasms
Interferon-alpha
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Interferons
Intestinal Diseases
Intestinal Neoplasms
Recurrence
Lymphatic Diseases
Digestive System Diseases
B-cell lymphomas
Peginterferon alfa-2b
Gastrointestinal Neoplasms
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Interferon Alfa-2a
Interferon Alfa-2b
Follicular lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Ileal Diseases
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Jejunal Diseases
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 03, 2008




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