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Sponsored by: |
Theradex |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053105 |
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 I |
Study Type: | Interventional |
Study Design: | 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:
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.
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:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
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 |
ClinicalTrials.gov Identifier: | NCT00053105 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma recurrent grade 3 follicular lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse |
Cisplatin Cutaneous T-cell Lymphoma Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Aggression Lymphoma, Large-cell Lymphoma Cytarabine Methylprednisolone Hemisuccinate Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Methylprednisolone acetate Glucocorticoids Immunosuppressive Agents |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Cisplatin |
Therapeutic Uses Lymphoma Cytarabine Methylprednisolone Hemisuccinate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Methylprednisolone acetate Glucocorticoids Protective Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions |