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A Phase II Study of Rituxan and IL-2 in Patients With Low Grade or Follicular B-Cell Lymphoma


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Phase II Study of Rituxan and IL-2 in Patients With Low Grade or Follicular B-Cell Lymphoma


OBJECTIVES: I. Determine the response rate in patients with low-grade, mantle cell, or
follicular B-cell lymphoma treated with a combination of rituximab and low-dose
interleukin-2 (IL-2). II. Determine the maximum tolerated dose of IL-2 when given in
conjunction with rituximab in this patient population. III. Assess whether antibody
dependent cellular cytotoxicity (ADCC) is enhanced by in vivo exposure to IL-2 and whether
ADCC activity correlates with clinical response in these patients. IV. Assess the incidence
of antirituximab antibody formation in these patients.

OUTLINE: Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 and rituximab IV
on day 3. Courses repeat weekly for up to 4 weeks in the absence of disease progression or
unacceptable toxicity. Patients are followed weekly for 4 weeks and then every 3 months for
1 year.

PROJECTED ACCRUAL: A total of 14-29 patients with low-grade/follicular lymphoma and 14-29
patients with mantle cell lymphoma will be accrued for this study within 2-5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage II-IV low-grade, mantle cell, or
follicular B-cell lymphoma Stage I disease is eligible only if radiotherapy is not
considered feasible due to location of disease or previous radiation treatments No chronic
lymphocytic lymphoma No small lymphocytic lymphoma with lymphocyte count greater than
5,000/mm3 Must be either first-line therapy or no more than 4 relapses after standard
therapies, including chemotherapy, radiotherapy, autologous bone marrow transplantation,
and/or immunotherapy Eligible if refractory to first treatment with a standard therapy
Patients refractory to autologous bone marrow transplantation (ABMT) or relapsed after
ABMT are eligible Patients with low-grade or follicular lymphoma must have failed at least
one chemotherapy regimen Patients with mantle cell lymphoma are eligible even if no prior
treatment Bidimensionally measurable disease Demonstrable monoclonal CD20-positive B-cell
population in lymph nodes or bone marrow No prior diagnosis of intermediate or high-grade
non-Hodgkin's lymphoma No CNS, pericardial, pleural, or peritoneal involvement by lymphoma
No AIDS-related lymphoma No pleural effusion No ascites 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 to 75 Performance status: ECOG 0-2 Life expectancy: At
least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 75,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 2.0
mg/dL Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) SGOT no
greater than 2 times ULN Renal: Creatinine clearance at least 65 mL/min Cardiovascular:
See Disease Characteristics No pericardial effusion No New York Heart Association class
III or IV heart disease No myocardial infarction within the past 6 months Other: No
active, uncontrolled bacterial, viral, or fungal infection No active opportunistic
infection No active inflammatory arthritis (excluding degenerative joint disease) No known
hypersensitivity to interleukin-2 No history of an autoimmune disorder No history of
seizure disorder No other primary malignancy in the past 5 years except squamous cell or
basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or
nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior
radioimmunotherapy At least 6 months since prior autologous bone marrow transplantation
and recovered At least 4 weeks since prior colony-stimulating factors or epoetin alfa At
least 3 weeks since prior immunotherapy and recovered No concurrent hematopoietic growth
factors Chemotherapy: See Disease Characteristics At least 3 weeks since prior
chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: At
least 3 weeks since prior corticosteroids No corticosteroids during or for 8 weeks after
study Radiotherapy: See Disease Characteristics See Biologic therapy At least 3 weeks
since prior radiotherapy and recovered Surgery: Not a recipient of an allogeneic organ
transplantation, unless organ is no longer functional At least 4 weeks since any prior
major surgery (except diagnostic surgery) and recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joseph D. Rosenblatt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066338

NCT ID:

NCT00003356

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular 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
  • stage I mantle cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I marginal zone lymphoma
  • stage I 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, B-Cell

Name

Location

University of Rochester Cancer CenterRochester, New York  14642