Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer
Study Details
Study Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (rituximab and 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. |
Biological: rituximab
Given IV
Other Names:
Biological: aldesleukin
Given SC
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
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Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
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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
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No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells
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Measurable or evaluable disease
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Must have failed standard curative therapy
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No CNS or leptomeningeal metastasis
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Performance status - Karnofsky 70-100%
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Performance status - ECOG 0-1
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At least 4 months
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Absolute neutrophil count at least 1,000/mm^3
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Hemoglobin at least 10 g/dL (transfusion allowed)
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Platelet count at least 50,000/mm^3
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AST no greater than upper limit of normal (ULN)
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Bilirubin no greater than 1.5 times ULN
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Hepatitis B surface antigen negative
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Creatinine no greater than ULN
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No prior unstable coronary artery disease
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No New York Heart Association class III or IV congestive heart failure
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DLCO and FEV1 at least 50% of predicted
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HIV negative
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No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
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No infection requiring IV antibiotic therapy within the past 4 weeks
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No other major illness that would preclude study
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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See Disease Characteristics
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Prior antibody therapy allowed
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Prior interleukin-2 or interferon alfa allowed
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See Disease Characteristics
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At least 4 weeks since prior chemotherapy
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At least 4 weeks since prior systemic corticosteroids
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At least 4 weeks since prior radiotherapy
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At least 4 weeks since prior surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Pierluigi Porcu, Ohio State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-01404
- 0037
- CDR0000068454
- OSU-0037
- NCI-130
- OSU-00H0223
- U01CA076576