Lymphoma Clinical Trial
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
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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