Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT00052884|
Recruitment Status : Terminated (Slow accrual and changes in clinical practice)
First Posted : January 27, 2003
Last Update Posted : December 3, 2012
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy.
PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.
|Condition or disease||Intervention/treatment||Phase|
|Drug/Agent Toxicity by Tissue/Organ Multiple Myeloma and Plasma Cell Neoplasm||Biological: filgrastim Drug: amifostine trihydrate Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation||Phase 1|
- Determine the maximum tolerated dose (MTD) of high-dose melphalan administered with amifostine in patients with primary systemic amyloidosis undergoing autologous peripheral blood stem cell transplantation.
- Determine the toxicity of high-dose melphalan when administered at the MTD in these patients.
- Determine the response rate in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of melphalan.
Patients receive filgrastim (G-CSF) subcutaneously once daily until peripheral blood stem cell (PBSC) collection is complete. Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected.
Within 6 weeks of PBSC collection, patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 30-60 minutes on day -1. Patients undergo autologous PBSC infusion on day 0.
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose.
Patients are followed approximately 3 months following transplantation, then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within 2.3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis|
|Study Start Date :||October 2003|
|Primary Completion Date :||September 2007|
|Study Completion Date :||March 2011|
Experimental: Amifostine, Melphalan, and Stem Cell Reconstitution
Amifostine, Melphalan, and Stem Cell Reconstitution. Doses of Melphalan tested included 100 mg/m2 and 120 mg/m2
|Biological: filgrastim Drug: amifostine trihydrate Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation|
- Maximum Tolerated Dose [ Time Frame: Assessed over 30 days ]The maximum tolerated dose is the highest dose level at which fewer than 1 of 3 or 2 of 6 patients experience dose-limiting toxicity, defined as any grade 3 or higher toxicity of any of the following: renal failure, alkaline phosphatase elevation, GI bleeding, and cardiac rhythm disturbances, assessed using NCI Common Toxicity Criteria, version 2.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052884
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Minnesota|
|Fairview Ridges Hospital|
|Burnsville, Minnesota, United States, 55337|
|Mercy and Unity Cancer Center at Mercy Hospital|
|Coon Rapids, Minnesota, United States, 55433|
|Fairview Southdale Hospital|
|Edina, Minnesota, United States, 55435|
|Mercy and Unity Cancer Center at Unity Hospital|
|Fridley, Minnesota, United States, 55432|
|Minnesota Oncology Hematology, PA - Maplewood|
|Maplewood, Minnesota, United States, 55109|
|Virginia Piper Cancer Institute at Abbott - Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center|
|Robbinsdale, Minnesota, United States, 55422-2900|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|Park Nicollet Cancer Center|
|St. Louis Park, Minnesota, United States, 55416|
|St. Paul, Minnesota, United States, 55102|
|Ridgeview Medical Center|
|Waconia, Minnesota, United States, 55387|
|Minnesota Oncology Hematology, PA - Woodbury|
|Woodbury, Minnesota, United States, 55125|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Morie A. Gertz, MD||Mayo Clinic|