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
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