Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer
- Conditions
- B-cell Adult Acute Lymphoblastic LeukemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular Lymphoma
- Interventions
- Biological: rituximabBiological: aldesleukinOther: laboratory biomarker analysisOther: pharmacological study
- Registration Number
- NCT00010192
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.
- Detailed Description
OBJECTIVES: Determine the dose-limiting toxicity of rituximab followed by low-dose and intermediate-dose pulse interleukin-2 (IL-2) in patients with CD20-positive B-cell lymphoid malignancy.
Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population.
Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of intermediate-dose pulse aldesleukin.
Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
-
Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
- Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
- Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation
-
No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells
-
Measurable or evaluable disease
-
Must have failed standard curative therapy
-
No CNS or leptomeningeal metastasis
-
Performance status - Karnofsky 70-100%
-
Performance status - ECOG 0-1
-
At least 4 months
-
Absolute neutrophil count at least 1,000/mm^3
-
Hemoglobin at least 10 g/dL (transfusion allowed)
-
Platelet count at least 50,000/mm^3
-
AST no greater than upper limit of normal (ULN)
-
Bilirubin no greater than 1.5 times ULN
-
Hepatitis B surface antigen negative
-
Creatinine no greater than ULN
-
No prior unstable coronary artery disease
-
No New York Heart Association class III or IV congestive heart failure
-
DLCO and FEV1 at least 50% of predicted
-
HIV negative
-
No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
-
No infection requiring IV antibiotic therapy within the past 4 weeks
-
No other major illness that would preclude study
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception
-
See Disease Characteristics
-
Prior antibody therapy allowed
-
Prior interleukin-2 or interferon alfa allowed
-
See Disease Characteristics
-
At least 4 weeks since prior chemotherapy
-
At least 4 weeks since prior systemic corticosteroids
-
At least 4 weeks since prior radiotherapy
-
At least 4 weeks since prior surgery
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (rituximab and aldesleukin) rituximab Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Treatment (rituximab and aldesleukin) aldesleukin Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Treatment (rituximab and aldesleukin) laboratory biomarker analysis Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Treatment (rituximab and aldesleukin) pharmacological study Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84.
- Primary Outcome Measures
Name Time Method MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0 2 weeks Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States