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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060203 |
RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: brostallicin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of the Safety and Efficacy of Brostallicin (PNU-166196A) in Adult Patients With Multiple Myeloma That Has Progressed on Prior Chemotherapy |
Study Start Date: | December 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 23-52 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria*:
Major criteria:
Minor criteria:
Measurable disease defined by 1 of the following values:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent chronic steroids
Radiotherapy
Surgery
Other
Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Hillard M. Lazarus, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000299536, CWRU-PHAR-1A02, PHARMACIA-196-ONC-0100-006 |
Study First Received: | May 6, 2003 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00060203 History of Changes |
Health Authority: | United States: Federal Government |
stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Recurrence Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |