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

NCT00003926 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-11-29

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • John P. Perentesis, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-11-30
Primary Completion
2002-08-31
Completion
2003-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003926 on ClinicalTrials.gov