Radiation Therapy Using Holmium Ho 166 DOTMP Plus Melphalan and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
NCT ID: NCT00004158
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
INTERVENTIONAL
1999-06-30
2006-01-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy using holmium Ho 166 DOTMP plus melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma.
Detailed Description
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OUTLINE: This is a dose escalation, multicenter study of targeted radiotherapy using holmium Ho 166 DOTMP. Phase I: Autologous or syngeneic peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells. Patients receive an initial test dose of holmium Ho 166 DOTMP IV. Patients with adequate skeletal uptake of the test dose then receive therapeutic dose holmium Ho 166 DOTMP IV over 5-10 minutes for 1-3 days beginning 2 days after test dose infusion and melphalan IV over 20-30 minutes on day -3. PBSC are reinfused beginning a minimum of 24 hours after melphalan infusion and after ongoing radiation to bone marrow falls to less than 1 rad/hour. Cohorts of 4-7 patients receive escalating doses of targeted radiotherapy using holmium Ho 166 DOTMP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 7 patients experience dose limiting toxicity. Phase II: Patients receive holmium Ho 166 DOTMP at the MTD from phase I of the study. Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 1 year.
Conditions
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Study Design
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TREATMENT
Interventions
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melphalan
peripheral blood stem cell transplantation
holmium Ho 166 DOTMP
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 to physiologic 65 Performance status: Zubrod 0-2 Life expectancy: Not severely limited by concurrent illness Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL SGPT less than 4 times normal Renal: Creatinine clearance at least 30 mL/min Cardiovascular: No uncontrolled arrhythmias or symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease FEV1, FVC, and DLCO at least 50% of predicted Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No spinal cord compression
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Prior external beam radiotherapy not to exceed 30 Gy to spinal cord or greater than 20% of bone marrow volume Surgery: Not specified Other: At least 1 month since prior bisphosphonates No other concurrent experimental agents
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Principal Investigators
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William I. Bensinger, MD
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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Sylvester Cancer Center, University of Miami
Miami, Florida, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Washington School of Medicine
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1442.00
Identifier Type: -
Identifier Source: secondary_id
NEORX-9804
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1623
Identifier Type: -
Identifier Source: secondary_id
CDR0000067396
Identifier Type: REGISTRY
Identifier Source: secondary_id
1442.00
Identifier Type: -
Identifier Source: org_study_id