Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: cisplatin Drug: cytarabine Drug: methylprednisolone Drug: pixantrone dimaleate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
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| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00053105 History of Changes |
| Other Study ID Numbers: | CDR0000269140, THERADEX-AZA-I-05, NOVUSPHARMA-AZA-I-05, NOVUSPHARMA-AZA-1401, CWRU-050213J |
| Study First Received: | January 27, 2003 |
| Last Updated: | July 4, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult diffuse large cell lymphoma recurrent grade 3 follicular lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pixantrone Cisplatin Cytarabine Methylprednisolone Hemisuccinate Prednisolone Methylprednisolone acetate Prednisolone acetate |
Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013