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Home > "B" Clinical Trials Conditions > Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma  Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
For Condition: refractory plasma cell neoplasm,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 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 - 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) - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HillardLazarus, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000299536; PHARMACIA-196-ONC-0100-006,CWRU-PHAR-1A02
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060203
Other Refractory Plasma Cell Neoplasm Studies:
1. Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
3. Total-Body Irradiation, Busulfan, and Interferon alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma
4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
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