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Combination Chemotherapy Plus Gene Therapy in Treating Patients With CNS Tumors

NCT00005796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-03-25

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 more than one drug may kill more tumor cells. Inserting a specific gene into a person's peripheral stem cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus gene therapy in treating patients who have CNS tumors.

Conditions

Interventions

PROCEDURE

filgrastim

GCSF is given after chemo administration

BIOLOGICAL

gene therapy

stem cells are collected and given back to the patients after chemotherapy adminstration

DRUG

lomustine

chemotherapy is administered every 21 days

DRUG

procarbazine hydrochloride

chemotherapy is administered every 21 days.

DRUG

vincristine sulfate

chemotherapy is administered every 21 days

PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

stem cells are reinfused after chemotherapy administration

Sponsors & Collaborators

  • Indiana University Melvin and Bren Simon Cancer Center

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • James Croop, MD, PhD · Riley's Children Cancer Center at Riley Hospital for Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2003-06-30
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00005796 on ClinicalTrials.gov