NCT00003926

Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors

A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 1 Year – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid tumors or brain tumors. * Determine response or time to disease progression in patients treated with this regimen. OUTLINE: This is a dose-escalation study of amifostine. Patients are stratified according to age (1 to 18 vs 19 to 45 years). All patients receive filgrastim (G-CSF) IV for 1 week. On day 6 of G-CSF administration, patients undergo peripheral blood stem cell (PBSC) harvest followed by chemotherapy. Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2. Patients receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. PBSC are reinfused on day 0. Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed on day 50; at 3, 6, and 9 months; and at 1, 2, and 3 years post PBSC transplantation. PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Conditions

• Brain and Central Nervous System Tumors
• Childhood Germ Cell Tumor
• Chordoma
• Kidney Cancer
• Liver Cancer
• Neuroblastoma
• Ovarian Cancer
• Retinoblastoma
• Sarcoma

Interventions

Type	Name	Description
DRUG	amifostine trihydrate	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.
DRUG	busulfan	Patients receive oral busulfan every 6 hours on days -8 to -6.
DRUG	filgrastim	All patients receive filgrastim (G-CSF) IV for 1 week.
DRUG	melphalan	melphalan intravenous (IV) over 30 minutes on days -5 and -4
DRUG	thiotepa	thiotepa intravenous (IV) over 2 hours on days -3 and -2.
PROCEDURE	peripheral blood stem cell transplantation (PBSC)	PBSC are reinfused on day 0

Timeline

• Start date: 1998-11-01
• Primary completion: 2002-08-01
• Completion: 2003-08-01
• First posted: 2003-05-02
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States