A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell 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.
Inclusion 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
Life expectancy:
- Not specified
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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Thomas E. Witzig, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000067714
NCT ID:
NCT00005601
Start Date:
October 2000
Completion Date:
Related Keywords:
- Lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
