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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005601 |
Purpose
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.
| Condition | Intervention | Phase |
|
Lymphoma |
Drug: cisplatin Drug: cytarabine Drug: dexamethasone Drug: rituximab |
Phase II |
| MedlinePlus related topics: | Cancer Lymphoma |
| Drug Information available for: | Cytarabine Cytarabine hydrochloride Cisplatin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Rituximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 Start Date: | October 2000 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Arizona | |||||
| CCOP - Scottsdale Oncology Program | |||||
| Scottsdale, Arizona, United States, 85259-5404 | |||||
| United States, Florida | |||||
| Mayo Clinic | |||||
| Jacksonville, Florida, United States, 32224 | |||||
| United States, Illinois | |||||
| CCOP - Illinois Oncology Research Association | |||||
| Peoria, Illinois, United States, 61602 | |||||
| United States, Iowa | |||||
| CCOP - Cedar Rapids Oncology Project | |||||
| Cedar Rapids, Iowa, United States, 52403-1206 | |||||
| CCOP - Iowa Oncology Research Association | |||||
| Des Moines, Iowa, United States, 50309-1016 | |||||
| Siouxland Hematology-Oncology | |||||
| Sioux City, Iowa, United States, 51101-1733 | |||||
| United States, Kansas | |||||
| CCOP - Wichita | |||||
| Wichita, Kansas, United States, 67214-3882 | |||||
| United States, Louisiana | |||||
| CCOP - Ochsner | |||||
| New Orleans, Louisiana, United States, 70121 | |||||
| United States, Michigan | |||||
| CCOP - Ann Arbor Regional | |||||
| Ann Arbor, Michigan, United States, 48106 | |||||
| United States, Minnesota | |||||
| CCOP - Duluth | |||||
| Duluth, Minnesota, United States, 55805 | |||||
| CCOP - Metro-Minnesota | |||||
| Saint Louis Park, Minnesota, United States, 55416 | |||||
| CentraCare Health Plaza | |||||
| Saint Cloud, Minnesota, United States, 56303 | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, Nebraska | |||||
| CCOP - Missouri Valley Cancer Consortium | |||||
| Omaha, Nebraska, United States, 68106 | |||||
| United States, North Dakota | |||||
| CCOP - Merit Care Hospital | |||||
| Fargo, North Dakota, United States, 58122 | |||||
| Medcenter One Health System | |||||
| Bismarck, North Dakota, United States, 58501 | |||||
| United States, Ohio | |||||
| CCOP - Toledo Community Hospital | |||||
| Toledo, Ohio, United States, 43623-3456 | |||||
| United States, Pennsylvania | |||||
| CCOP - Geisinger Clinic and Medical Center | |||||
| Danville, Pennsylvania, United States, 17822-2001 | |||||
| United States, South Dakota | |||||
| CCOP - Sioux Community Cancer Consortium | |||||
| Sioux Falls, South Dakota, United States, 57104 | |||||
| Rapid City Regional Hospital | |||||
| Rapid City, South Dakota, United States, 57709 | |||||
| Canada, Saskatchewan | |||||
| Allan Blair Cancer Centre | |||||
| Regina, Saskatchewan, Canada, S4T 7T1 | |||||
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Witzig TE, Geyer SM, Kurtin PJ, Colgan JP, Inwards DJ, Micallef IN, Laplant BR, Michalak JC, Salim M, Dalton RJ, Moore DF Jr, Reeder CB. Salvage chemotherapy with rituximab DHAP for relapsed non-Hodgkin lymphoma: A phase II trial in the North Central Cancer Treatment Group. Leuk Lymphoma. 2008 Jun;49(6):1074-80.
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Witzig TE, Geyer SM, Kurtin PJ, et al.: Salvage chemotherapy with rituximab DHAP (RDHAP) for relapsed non-hodgkin lymphoma (NHL): a phase II trial in the North Central Cancer Treatment Group. [Abstract] J Clin Oncol 24 (Suppl 18): A-7574, 440s, 2006.
  |
| Study ID Numbers: | CDR0000067714, NCCTG-N9981 |
| First Received: | May 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005601 |
| Health Authority: | United States: Federal Government |
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