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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma  Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
For Condition: Non-Hodgkin's Lymphoma,Lymphoblastic Lymphoma
Status: Completed
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine response rate to cisplatin, cytarabine, and dexamethasone (DHAP) plus rituximab in patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma. - Determine the percentage of patients able to proceed to transplant after two courses of this treatment regimen. - Determine the duration of response and overall survival of the patients not proceeding to transplant after two courses of this treatment regimen. OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study within 11 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma - Relapsed following chemotherapy and eligible for platinum-containing regimen - Measurable disease - Must be at least 1.5 x 1.5 cm PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: - No uncontrolled hypertension Other: - HIV negative - No other active malignancy - No uncontrolled diabetes mellitus - No uncontrolled peptic ulcer disease - No uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWitzig, Study Chair, Mayo Clinic Cancer Center
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Additional Information:
Study ID Numbers: CDR0000067714; NCCTG-N9981
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005601
Other Lymphoblastic Lymphoma Studies:
1. Monoclonal Antibody Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma
2. Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Related Studies:
Other Lymphoblastic Lymphoma Clinical Trials
Other Arizona Clinical Trials
Other Scottsdale Clinical Trials
Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
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