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Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: B-cell Adult Acute Lymphoblastic Leukemia; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Small Lymphocytic Lymphoma

Intervention: rituximab (Biological); aldesleukin (Biological); laboratory biomarker analysis (Other); pharmacological study (Other)

Phase: Phase 1

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Pierluigi Porcu, Principal Investigator, Affiliation: Ohio State University

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.

Clinical Details

Official title: A Phase I Trial Of Rituximab And Interleukin-2

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ohio State University Medical Center, Columbus, Ohio 43210, United States
Additional Information

Starting date: December 2000
Last updated: June 5, 2013

Page last updated: August 23, 2015

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