Completed

A Phase I/II Study of Targeted Radiotherapy Using Holmium-166-DOTMP With Melphalan and Peripheral Blood Stem Cell Transplantation for Treatment of Multiple Myeloma

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What is being tested

melphalan

+ peripheral blood stem cell transplantation

+ holmium Ho 166 DOTMP

DrugProcedureRadiation
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: June 1999
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Last updated: September 21, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the maximum tolerated dose of targeted radiotherapy using holmium Ho 166 DOTMP when combined with melphalan and autologous or syngeneic peripheral blood stem cell transplantation in patients with multiple myeloma. II. Determine the response rate and time to progression in patients treated with this regimen. 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.

NCT00004158
Principal SponsorFred Hutchinson Cancer Center
Last updated: September 21, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersMultiple MyelomaNeoplasms, Plasma Cell

Criteria

DISEASE CHARACTERISTICS: Multiple myeloma with one of the following: Complete or partial response to initial chemotherapy OR Primary refractory disease OR Chemotherapy responsive relapse Undergoing autologous or syngeneic peripheral blood stem cell transplantation No myeloma in refractory relapse 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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Sylvester Cancer Center, University of Miami

Miami, United StatesOpen Sylvester Cancer Center, University of Miami in Google Maps

University of Texas - MD Anderson Cancer Center

Houston, United States

Fred Hutchinson Cancer Research Center

Seattle, United States

University of Washington School of Medicine

Seattle, United States
Completed4 Study Centers