NCT Number: NCT00005601
Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed 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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Cisplatin
DrugCytarabine
DrugDexamethasone
DrugSargramostim
DrugPrimary outcomes
-
response
Time frame: Up to 5 years
Secondary outcomes
-
percentage of patients able to proceed to transplant after two courses of this treatment regimen
Time frame: Up to 5 years
-
duration of response
Time frame: Up to 5 years
-
overall survival
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma
Important dates
- Study start
- 2000
- Primary completion
- 2003
- Study completion
- 2008
- First posted
- Jan 27, 2003
- Registry last updated
- Dec 7, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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