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| Sponsor: | Theradex |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053105 |
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 I |
| 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:
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:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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
| 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 |
|
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 Pixantrone Cisplatin Cytarabine Methylprednisolone Hemisuccinate Prednisolone Methylprednisolone acetate Prednisolone acetate |
Methylprednisolone 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 Anti-Inflammatory Agents |