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Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B (PEGIntron) in Advanced Stage Low Grade Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Small Intestine Cancer

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Trial Information

Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B (PEGIntron) in Advanced Stage Low Grade Non-Hodgkin's Lymphoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Carol S. Portlock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-101

NCT ID:

NCT00006039

Start Date:

December 1999

Completion Date:

March 2001

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021