Expired Study
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Columbus, Ohio 43210


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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


NCT ID:

NCT00010192


Primary Contact:

Principal Investigator
Pierluigi Porcu
Ohio State University


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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