Non Hodgkin Lymphoma Clinical Trial
Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma
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.
Full 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 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
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
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There are 21 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Peoria Illinois, 61602, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
Sioux City Iowa, 51101, United States
Wichita Kansas, 67214, United States
New Orleans Louisiana, 70121, United States
Ann Arbor Michigan, 48106, United States
Duluth Minnesota, 55805, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
Omaha Nebraska, 68106, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58122, United States
Toledo Ohio, 43623, United States
Danville Pennsylvania, 17822, United States
Rapid City South Dakota, 57709, United States
Sioux Falls South Dakota, 57104, United States
Regina Saskatchewan, S4T 7, Canada
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