Withdrawn due to slow accrual
A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors
Sponsor study identifier
Secondary identifiers
OTHER · Blood and Marrow Transplantation Program
OTHER · IRB, University of Minnesota
interventional
13
1 country
1
Study Start
November 1998
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2002
Actual (reported)Study Completion
August 2003
Actual (reported)RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2003
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1998
Date type not reportedThis date has not been verified as actual or estimated.
November 1, 1999
Actual (reported)August 2002
Actual (reported)May 2, 2003
Actual (reported)August 2003
Actual (reported)Patients with solid tumor or brain tumor in the 1-18 years old stratum.
Patients with solid tumor or brain tumor in the 19-45 years old stratum.
Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined.
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
John P. Perentesis, MD
Masonic Cancer Center, University of Minnesota
13 participants (actual enrollment reported by the registry).
First Submitted
November 1, 1999
First Posted
May 2, 2003
Study Start
November 1998
Date type not reportedThis date has not been verified as actual or estimated.
Patients receive oral busulfan every 6 hours on days -8 to -6.
All patients receive filgrastim (G-CSF) IV for 1 week.
melphalan intravenous (IV) over 30 minutes on days -5 and -4
thiotepa intravenous (IV) over 2 hours on days -3 and -2.
PBSC are reinfused on day 0
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 2002
Actual (reported)Study Completion
August 2003
Actual (reported)Last Updated
November 29, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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