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Spots Global Cancer Trial Database for Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Official Title: A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma

Study ID: NCT00005601

Conditions

Lymphoma

Study Description

Brief Summary: 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.

Detailed Description: 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States

Mayo Clinic, Jacksonville, Florida, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

Siouxland Hematology-Oncology, Sioux City, Iowa, United States

CCOP - Wichita, Wichita, Kansas, United States

CCOP - Ochsner, New Orleans, Louisiana, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States

CCOP - Duluth, Duluth, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CentraCare Health Plaza, Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Medcenter One Health System, Bismarck, North Dakota, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

CCOP - Toledo Community Hospital, Toledo, Ohio, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Contact Details

Name: Thomas E. Witzig, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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