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Home > "R" Clinical Trials Conditions > Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma  Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma
Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma
For Condition: Waldenstrom's Macroglobulinemia,recurrent grade 1 follicular lymphoma,recurrent grade 2 follicular lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent mantle cell lymphoma
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , 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-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells. PURPOSE: Randomized phase II trial to compare the effectiveness of rituximab with or without interleukin-12 in treating patients who have non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the objective response in patients with B-cell non-Hodgkin's lymphoma treated with rituximab with or without interleukin-12. - Compare the toxic effects of these regimens in these patients. - Determine the objective response rate in patients with mantle cell lymphoma treated with these regimens. - Determine the overall and progression-free survival of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (mantle cell lymphoma vs other) and International Prognostic Factor Index (low and low-intermediate risk vs high-intermediate and high risk). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive interleukin-12 subcutaneously (SC) twice weekly beginning on day 2 and continuing until disease progression. - Arm II: Patients receive rituximab as in arm I. Patients are evaluated at week 12. Patients with stable or progressive disease receive interleukin-12 SC twice weekly until disease progression or for 24 weeks. Patients with a complete or partial response after rituximab are monitored until disease progression and then begin interleukin-12 SC twice weekly until further disease progression. Quality of life is assessed at baseline and at 3 and 6 months. Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years. PROJECTED ACCRUAL: A total of 90 patients (45 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma - Previously treated low-grade lymphoma considered incurable with standard therapy - Grade I or II follicular lymphoma - Lymphoplasmacytic lymphoma - Small lymphocytic lymphoma - Nodal marginal zone lymphoma - Extranodal marginal zone lymphoma of MALT type - Splenic marginal zone lymphoma - Previously treated mantle cell lymphoma allowed - Meets one of the following criteria for measurable disease: - Bidimensional diameter at least 1.5 cm by 1.5 cm on physical exam - At least 2 cm in one dimension by CT scan, MRI, or plain radiograph imaging - Palpable spleen at least 5 cm below the left costal margin - No CNS involvement by lymphoma 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 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic: - Bilirubin no greater than 3 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN Renal: - Creatinine no greater than 2 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease - No history of angina Other: - No uncontrolled peptic ulcer disease - No uncontrolled infection - No other active malignancy - No autoimmune-related phenomena (e.g., antinuclear antibody less than 2 times ULN, rheumatoid factor less than 2 times ULN, and negative direct Coombs) - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior stem cell transplantation allowed - More than 12 months since prior rituximab - No prior interleukin-12 - No other concurrent immunotherapy Chemotherapy: - Recovered from prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - No concurrent steroid therapy Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - Any number of prior therapies allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenAnsell, Study Chair, Mayo Clinic Cancer Center
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Medcenter One Health System
Bismark, North Dakota, 58501-5505
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Additional Information:
Study ID Numbers: CDR0000068994; NCCTG-N0087
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026182
Other Recurrent Mantle Cell Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma
3. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
4. Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent mantle cell lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma
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