Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Status: | Completed |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2000 |
End Date: | February 2008 |
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.
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.
- 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.
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
We found this trial at
21
sites
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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