Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00053105 |
Recruitment Status : Unknown
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 28, 2003
Last Update Posted : July 7, 2009
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: cisplatin Drug: cytarabine Drug: methylprednisolone Drug: pixantrone dimaleate | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2002 |


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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053105
United States, Arizona | |
Arizona Clinical Research Center | |
Tucson, Arizona, United States, 85712 | |
United States, Arkansas | |
Highlands Oncology Group | |
Springdale, Arkansas, United States, 72764 | |
United States, California | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033-0800 | |
United States, Maryland | |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5055 | |
United States, Tennessee | |
Boston Baskin Cancer Group, University Tennessee | |
Memphis, Tennessee, United States, 38104 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Luis Fayad, MD | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00053105 |
Other Study ID Numbers: |
CDR0000269140 THERADEX-AZA-I-05 NOVUSPHARMA-AZA-I-05 NOVUSPHARMA-AZA-1401 CWRU-050213J |
First Posted: | January 28, 2003 Key Record Dates |
Last Update Posted: | July 7, 2009 |
Last Verified: | March 2003 |
recurrent adult diffuse large cell lymphoma recurrent grade 3 follicular lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma |
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Methylprednisolone Pixantrone Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents |