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

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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.

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
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
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Ann Arbor, Michigan 48106
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Bismarck, North Dakota 58501
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Bismarck, ND
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Cedar Rapids, Iowa 52403
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Danville, Pennsylvania 17822
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Danville, PA
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300 East Locust St., Ste 350
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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Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Fargo, North Dakota 58122
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New Orleans, Louisiana 70121
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New Orleans, LA
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Rapid City, SD
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Regina, Saskatchewan
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Regina,
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Saint Cloud, Minnesota 56303
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Saint Cloud, MN
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Saint Louis Park, Minnesota 55416
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Scottsdale, Arizona 85259
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Sioux City, Iowa 51101
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Sioux Falls, South Dakota 57104
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Toledo, OH
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Wichita, Kansas 67214
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Wichita, KS
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