- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045136
Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer cells and cause less damage to normal tissue. Combining chemotherapy and holmium Ho 166 DOTMP with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and holmium Ho 166 DOTMP and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining holmium Ho 166 DOTMP with melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the radiation absorbed dose of holmium Ho 166 DOTMP to the kidney in patients with multiple myeloma, based on whole body gamma camera image data for comparison with that obtained using an ICRP mathematical model.
- Determine the average marrow dose of this drug in these patients using gamma camera whole body counts in patients receiving this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Compare marrow dose estimates determined from gamma camera whole-body counts and thyroid uptake probe counts in patients receiving this drug.
- Evaluate intra-patient variability of the uptake of this drug in the bone with repeat tests.
- Determine whether the biodistribution and dosimetry is influenced by administering this drug as a bolus compared to a 15-minute infusion in these patients.
- Compare the reduction in dose rate from the 15-minute infusion vs the bolus injection of this drug to estimate the effect on kidney exposure in these patients.
- Determine the renal transit time for each patient after bolus injection of this drug and assess whether this information improves the dose estimate to kidney with the mathematical model.
- Determine whether there is correlation of renal transit time from technetium Tc 99m-diethylenetriaminepentaacetic acid (DTPA) with holmium Ho 166 DOTMP.
- Determine the adverse events in patients receiving this drug.
- Determine the efficacy of a targeted therapy dose of holmium Ho 166 DOTMP with melphalan followed by autologous peripheral blood stem cell transplantation in these patients.
OUTLINE: This is a multicenter study. Patients are entered into one of two cohorts.
- Cohort A: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on day 1 and then IV bolus on day 8.
- Cohort B: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on days 1 and 8.
After each diagnostic dose, patients in both cohorts also undergo gamma camera imaging of the whole body on days 1 and 8.
Approximately 1-3 weeks later, patients in both cohorts who demonstrate adequate uptake of the first diagnostic dose of holmium Ho 166 DOTMP into the bone marrow then receive therapeutic holmium Ho 166 DOTMP IV over 15 minutes once between days -13 to -10 followed by melphalan IV over 20-30 minutes once between days -10 to -1. Patients undergo autologous peripheral blood stem cell transplantation on day 0.
Patients are followed monthly for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A minimum of 12 patients (6 per cohort) will be accrued for this study.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294-0006
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Sacramento, California, United States, 95817
- University of California Davis Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37212
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
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Texas
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma (MM)
- Patients with a prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma are eligible if they progressed and met the criteria for diagnosis of MM
- No non-secretory MM
- No symptomatic MGUS, smoldering MM, or indolent MM
- No solitary bone or extramedullary plasmacytoma
- No immunoglobulin M myeloma
- Prior induction therapy for myeloma required
- Responding, stable, or progressive disease after induction therapy, or relapsed disease
- Candidate for autologous hematopoietic stem cell transplantation
Prior stem cell mobilization with chemotherapy and growth factors according to institutional procedures
- Availability of at least 2,000,000 CD34+ cells/kg
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2 mg/dL
- SGPT no greater than 2 times upper limit of normal
- No clinical evidence of amyloidosis of the liver
Renal
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 45 mL/min
- Renal ultrasound normal
- No clinical evidence of amyloidosis of the kidney
- No urinary obstruction in the renal pelvis, ureter, or bladder outlet by ultrasound
Cardiovascular
- Ejection fraction at least 50% with no evidence of amyloidosis by echocardiogram
- No clinical evidence of amyloidosis of the heart
- No uncontrolled arrhythmia
- No symptomatic cardiac disease
Pulmonary
- FEV1, FVC, and DLCO at least 60%
- No symptomatic pulmonary disease
- No clinical evidence of amyloidosis of the lungs
Other
- No known allergy to vitamin C or bisphosphonates
- No known hypersensitivity to technetium Tc 99m phosphorus radiopharmaceuticals (e.g., technetium Tc 99m-methylene diphosphonate)
- No concurrent illness that would severely limit life expectancy
- No symptoms, physical findings, or radiographic evidence of cord compression
- No clinical evidence of amyloidosis of the autonomic nervous system or gastrointestinal tract
- No prior noncompliance in other studies
- No other malignancy within the past 5 years except treated indolent skin cancers or carcinoma in situ of the cervix
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior stem cell or bone marrow transplantation
- No concurrent maintenance therapy comprising interferon or thalidomide
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- See Disease Characteristics
- No concurrent maintenance therapy comprising dexamethasone
Radiotherapy
- No prior cumulative external-beam radiotherapy (EBRT) to more than 20% of bone marrow
- No prior cumulative EBRT dose of 30 Gy or more to the spinal cord
- No prior radiotherapy to the bladder
Surgery
- See Disease Characteristics
Other
- At least 4 weeks since prior investigational agents for MM
- At least 4 weeks since other prior experimental therapies for any other condition
- No bisphosphonates for at least 4 weeks before study, during study, and for at least 30 days posttransplantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wendy Jenkins, Poniard Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
Other Study ID Numbers
- CDR0000256377
- PONIARD-0102
- NEORX-0102
- FHCRC-1704.00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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