Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I Trial Of Rituximab And Interleukin-2
| Verified date | June 2013 |
| Source | National Cancer Institute (NCI) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | January 2003 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Ohio State University Medical Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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