Lymphoma Clinical Trial
Official title:
A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Verified date | March 2003 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when
treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
Status | Active, not recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following: - Diffuse large B-cell lymphoma - Transformed NHL - Follicular large cell lymphoma - Peripheral T-cell lymphoma - Unclassified aggressive histology (immunoblastic lymphoma) - Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m^2) - No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age - 18 to 64 Performance status - WHO 0-1 Life expectancy - At least 3 months Hematopoietic - Neutrophil count at least 1,500/mm^3* - Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if evidence of bone marrow involvement Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)** - Alkaline phosphatase no greater than 2 times ULN** - AST or ALT no greater than 2 times ULN** - No history or clinical symptoms of hepatitis B or C virus NOTE: **Higher values may be accepted if evidence of liver involvement Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - LVEF at least 50% by MUGA - No clinically significant cardiovascular abnormalities - No New York Heart Association class II-IV heart disease - No myocardial infarction within the past 6 months - No severe arrhythmia - No uncontrolled hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study - No history or clinical symptoms of HIV - No clinically significant neurological abnormalities - No serious uncontrolled infection (NCI CTC grade 3-4) - No condition that would place the patient at undue risk or interfere with the study results PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior radioimmunotherapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - At least 1 year since prior platinum or cytarabine (unless complete response to treatment) - At least 2 years since prior fludarabine or nitrosoureas - No prior cumulative cisplatin greater than 600 mg/m^2 Endocrine therapy - Not specified Radiotherapy - See Biologic therapy - At least 4 weeks since prior radiotherapy - No prior radiotherapy to the whole pelvis Surgery - At least 1 week since prior minor surgery and recovered - At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered Other - At least 1 month since prior investigational drugs - Recovered from prior therapy - No other concurrent investigational drugs |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Boston Baskin Cancer Group, University Tennessee | Memphis | Tennessee |
United States | Highlands Oncology Group | Springdale | Arkansas |
United States | Arizona Clinical Research Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Theradex |
United States,
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