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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00059904 |
Purpose
RATIONALE: 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.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|
Lymphoma |
Drug: aldesleukin Drug: rituximab |
Phase II |
| MedlinePlus related topics: | Cancer Lymphoma |
| Drug Information available for: | Aldesleukin Rituximab Interleukin-2 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology |
| Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following:
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent immunosuppressive medications including the following:
Contacts and Locations| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Tarun Kewalramani, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000298986, MSKCC-03004, CHIR-IL2005-A01 |
| First Received: | May 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00059904 |
| Health Authority: | United States: Federal Government |
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