Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
This trial is active, not recruiting.
|Treatments||cisplatin, cytarabine, methylprednisolone, pixantrone dimaleate|
|Start date||February 2002|
|Trial identifier||NCT00053105, CDR0000269140, CWRU-050213J, NOVUSPHARMA-AZA-1401, NOVUSPHARMA-AZA-I-05, THERADEX-AZA-I-05|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Tucson, AZ||Arizona Clinical Research Center||no longer recruiting|
|Springdale, AR||Highlands Oncology Group||no longer recruiting|
|Los Angeles, CA||USC/Norris Comprehensive Cancer Center and Hospital||no longer recruiting|
|Baltimore, MD||Marlene and Stewart Greenebaum Cancer Center, University of Maryland||no longer recruiting|
|Cleveland, OH||Ireland Cancer Center||no longer recruiting|
|Memphis, TN||Boston Baskin Cancer Group, University Tennessee||no longer recruiting|
|Houston, TX||University of Texas - MD Anderson Cancer Center||no longer recruiting|
Male or female participants from 18 years up to 64 years old.
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
|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|
|Description||OBJECTIVES: - Determine the maximum tolerated dose and recommended dose of pixantrone when administered with cytarabine, methylprednisolone, and cisplatin in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. - Determine the dose-limiting toxic effects of this regimen in these patients. - Determine the relationship between toxicity and systemic exposure to this regimen in these patients. - Determine the safety of this regimen in these patients. - Assess the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the efficacy of this regimen in these patients. OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of pixantrone. Patients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is defined as the dose preceding the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.|
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