|
Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma Clinical research trials and Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma. Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma  Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma
Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma
For Condition: recurrent adult diffuse large cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent adult diffuse mixed cell lymphoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 refractoryintermediate- or high-gradenon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma. - Determine the 2-year progression-free survival of patients treated with this regimen. - Determine the safety of this regimen in these patients. - Correlate response with natural killer cell numbers and rituximab, interleukin-2 (IL-2), and soluble IL-2 receptor levels in patients treated with this regimen. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes: - Diffuse large cell lymphoma - Diffuse mixed cell lymphoma - Immunoblastic large cell lymphoma - CD20+ disease - Measurable progressive or refractory disease - No primary CNS lymphoma or lymphomatous meningitis NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Lymphocyte count less than 20,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 9.5 g/dL Hepatic - SGOT and SGPT no greater than 1.5 times upper limit of normal - Bilirubin normal - No liver disease - Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following: - Undetectable hepatitis C viral loads - Biopsy showing no active disease - Normal transaminases on at least 3 different occasions within the past year Renal - Creatinine normal Cardiovascular - No clinically significant cardiac dysfunction - No myocardial infarction within the past 6 months - No heart failure within the past 6 months Pulmonary - No clinically significant pulmonary dysfunction - Patients with prior radiotherapy to the lung or autologous transplantation must have FEV greater than 50% and DLCO greater than 50% within 8 weeks before study treatment Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No significant infections within the past 2 weeks (including pneumonia or bronchitis) - No history of autoimmune disease - No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other solid tumor curatively treated with no evidence of recurrence within the past 2 years - No symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism - No prior type 1 hypersensitivity or anaphylactic reactions to murine products, rituximab, or radioimmunoconjugated anti-CD20 antibody infusion PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior autologous bone marrow transplantation - No prior allogeneic bone marrow transplantation - No prior interleukin-2 - No prior interferon (alfa, beta, or gamma) - No concurrent basiliximab, daclizumab, or monoclonal antibody OKT3 Chemotherapy - More than 30 days since prior chemotherapy - No concurrent anticancer chemotherapy Endocrine therapy - More than 2 weeks since prior systemic steroids - No concurrent systemic corticosteroids Radiotherapy - More than 30 days since prior radiotherapy - No concurrent radiotherapy Surgery - More than 30 days since prior major surgery Other - More than 30 days since other prior investigational drugs - More than 30 days since prior immunosuppressive medications - No concurrent immunosuppressive medications including the following: - Cyclosporine - Mycophenolate mofetil - Tacrolimus - Sirolimus
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TarunKewalramani, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Tarun Kewalramani 212-639-3069
Additional Information:
Study ID Numbers: CDR0000298986; MSKCC-03004,CHIR-IL2005-A01
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059904
Other Recurrent Adult Diffuse Mixed Cell Lymphoma Studies:
1. Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
2. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Older Patients With Refractory or Relapsed Intermediate-Grade Non-Hodgkin's Lymphoma
3. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
4. Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma
5. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma
Related Studies:
Other recurrent adult diffuse mixed cell lymphoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma
|
|
|
|
|
|
|
|
