This trial is active, not recruiting.

Condition lymphoma
Treatments cisplatin, cytarabine, methylprednisolone, pixantrone dimaleate
Phase phase 1
Sponsor Theradex
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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).