Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

OBJECTIVES: - Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma. - Determine the maximum tolerated dose of this drug in these patients. - Determine the time to and duration of response, time to treatment failure, time to tumor progression, and survival in patients treated with this drug. - Determine the safety and tolerability of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Correlate baseline whole blood levels and activity of glutathione with clinical outcome in patients treated with this drug. OUTLINE: This is an open-label, multicenter, dose-escalation study. - Phase I: Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. - Phase II: Additional patients are accrued and treated at the MTD of brostallicin as in phase I. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 23-52 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria*: - Major criteria: - Plasmacytoma on tissue biopsy - Bone marrow plasmacytosis with at least 30% plasma cells - Monoclonal globulin spike on serum electrophoresis exceeding 3.5 g/dL for IgG peaks or 2.0 g/dL for IgA peaks; greater than 1,000 mg/24hr of kappa or gamma light chain excretion on urine electrophoresis in the absence of amyloidosis - Minor criteria: - Bone marrow plasmacytosis with 10% to 30% plasma cells - Monoclonal globulin spike present but less than levels in major criterion III above - Lytic bone lesions - Residual normal immunoglobulin M (IgM) no greater than 0.5 g/dL, IgA no greater than 0.1 g/dL, or IgG no greater than 0.6 g/dL NOTE: *Diagnosis of multiple myeloma requires a minimum of 1 major and 1 minor criterion (I and a together is not sufficient; must be I and b, I and c, I and d; II and b, II and c, II and d; III and a, III and c, III and d) or 3 minor criteria that must include a and b (a, b, and c; a, b, and d) - Measurable disease defined by 1 of the following values: - Serum myeloma (M) protein (IgG or IgA) level greater than 1.0 g/dL - Urine M protein (light chain disease) at least 300 mg/24hr - Soft tissue plasmacytoma with bidimensional measurement at least 20 x 20 mm (10 x 10 mm if spiral CT scan is used) - Must have progressed during or within 12 months of discontinuing prior myelosuppressive chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone (VAD) or melphalan) OR not responded after 2 courses of prior myelosuppressive chemotherapy - No indolent or smoldering myeloma or localized plasmacytoma - No known brain or leptomeningeal disease unless such lesions were previously irradiated, are currently not being treated with corticosteroids, and are associated with no clinical symptoms PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 (at least 1,000/mm^3 if neutropenia due to replacement of the normal bone marrow cells by myeloma cells) - Platelet count at least 100,000/mm^3 (at least 50,000/mm^3 if thrombocytopenia due to replacement of the normal bone marrow cells by myeloma cells) - Hemoglobin at least 8.0 g/dL (no transfusion allowed) - No hyperviscosity syndrome Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine no greater than 3.0 times ULN - Calcium no greater than 12 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and sampling for study analysis - HIV negative - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No AIDS-related illness - No active infectious process or other severe concurrent disease that would make the patient inappropriate for study entry - No mental incapacity or psychiatric illness that would preclude giving informed consent or completing follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - See Chemotherapy - No concurrent anticancer biological response modifiers - No concurrent immunotherapy - No concurrent sargramostim (GM-CSF) Chemotherapy - See Disease Characteristics - More than 2 years since prior high-dose chemotherapy with autologous bone marrow transplantation or stem cell support - More than 4 weeks since prior myelosuppressive chemotherapy - No other concurrent anticancer chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent anticancer hormonal therapy - No concurrent chronic steroids - Acute pulse dosing required for treatment of a concurrent medical condition is allowed, provided treatment duration is no greater than 2 weeks - No concurrent corticosteroids (e.g., dexamethasone) Radiotherapy - More than 14 days since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow - No plans for radiotherapy within the next 6 months - Concurrent palliative radiotherapy for skeletal pain allowed Surgery - More than 14 days since prior surgery - No plans for surgery within the next 6 months Other - Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline - Treatment-related neurotoxicity must have resolved to the patient's baseline, not to exceed grade 2 - Chronic bisphosphonates for bone pain allowed only for maintenance doses - More than 2 weeks since prior nonmyelosuppressive antimyeloma therapy - More than 2 weeks since prior macrolide antibiotics - No other concurrent investigational agents - No concurrent macrolide antibiotics - No concurrent participation in another treatment clinical study


NCT ID:

NCT00060203


Primary Contact:

Study Chair
Hillard M. Lazarus, MD
Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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