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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma  Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
For Condition: recurrent cutaneous T-cell lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult diffuse large cell lymphoma,recurrent adult immunoblastic large cell lymphoma
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: 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 effectiveness of combination chemotherapy in treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry Criteria: 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 - * 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LuisFayad, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Highlands Oncology Group
Springdale, Arkansas, 72764
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5055
United States
Boston Baskin Cancer Group, University Tennessee
Memphis, Tennessee, 38104
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0800
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Additional Information:
Study ID Numbers: CDR0000269140; THERADEX-AZA-I-05,NOVUSPHARMA-AZA-1401,CWRU-050213J,NOVUSPHARMA-AZA-I-05
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053105
Other Recurrent Grade Iii Follicular Large Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma That Has Not Responded to Previous Treatment
2. Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Large Cell Lymphoma
3. Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
5. Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade III follicular large cell lymphoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
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