CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 target
Drug / intervention
filgrastim +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003425
NCT00003425Phase 2Completed

Phase I/II Study of Escalating Dose Melphalan With Autologous Pluripotent Hematopoietic Stem Cell Support and Amifostine Cytoprotection in Cancer Patients

University of Kentucky·interventional·Posted Feb 20, 2004·Updated Apr 26, 2013

In Brief

A Phase 2 clinical trial evaluating filgrastim, amifostine trihydrate, and 3 other interventions for Breast Cancer and 6 related conditions. Completed, enrolled 25 participants across 4 sites.

Detailed 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 chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2004
Enrollment StartDec 1, 1997
Primary CompletionJul 1, 2002
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 22.4 years ago

Interventions

filgrastimbiological

amifostine trihydratedrug

cyclophosphamidedrug

melphalandrug

peripheral blood stem cell transplantationprocedure