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| ID | Type | Description | Link |
|---|---|---|---|
| 0037 | |||
| CDR0000068454 | |||
| OSU-0037 | |||
| NCI-130 | |||
| OSU-00H0223 | |||
| U01CA076576 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (rituximab and aldesleukin) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0 | Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level. | 2 weeks |
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Inclusion Criteria:
Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
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
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| Name | Affiliation | Role |
|---|---|---|
| Pierluigi Porcu | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| aldesleukin | Biological | Given SC |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| pharmacological study | Other | Correlative studies |
|
|
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C082598 | aldesleukin |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D008222 | Lymphokines |
| D001685 | Biological Factors |
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