Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045136
Status:
COMPLETED
Last Update Posted:
2009-04-03
First Post:
2002-09-06
Brief Title:
Chemotherapy Holmium Ho 166 DOTMP and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
Poniard Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 III 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
PURPOSE Phase III 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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-170400 | None | None | None |
| PONIARD-0102 | None | None | None |
| NEORX-0102 | None | None | None |