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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma

NCT00002601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-03-03

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or recurrent sarcoma.

Conditions

  • Sarcoma

Interventions

BIOLOGICAL

filgrastim

5 ug/kg daily following stem cell reinfusion

DRUG

cisplatin

Course 2 - 100 mg/m2 at an infusion rate of 25 mg/hr

DRUG

doxorubicin hydrochloride

Course 1 - 150 mg/m2 by continuous intravenous infusion for 96 hours.

DRUG

ifosfamide

Course 1 - 14 gm/M2 by continuous intravenous infusion for 96 hours.

DRUG

melphalan

Course 2 - 75 mg/m2 infused at a rate of 5 mg/minute

PROCEDURE

peripheral blood stem cell transplantation

Administered on Day 0 following high-dose chemotherapy in both courses 1 and 2

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • George Somlo, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00002601 on ClinicalTrials.gov