CLINICAL TRIAL SUMMARY

MDACC Study No:2007-0028 (clinicaltrials.gov NCT No: NCT00528437)
Title:High dose Temozolomide, Thiotepa, and Carboplatin with Autologous Stem Cell Rescue (ASCR) Followed by Continuation Therapy with 13-cis-retinoic Acid in Patients with Recurrent/Refractory Malignant Brain Tumors
Principal Investigator:Laura L. Worth
Treatment Agent:13-Cis Retinoic Acid; Carboplatin; Temozolomide; Thiotepa
Study Status:Closed
Study Description:The goal of this clinical research study is to learn the effects of
temozolomide, thiotepa, and carboplatin with a stem cell transplant followed by
13-cis-retinoic acid (isotretinoin) in children and adolescents with brain
tumors that have not responded to treatment or have come back after treatment.

Researchers also hope to learn how the body uses isotretinoin and how well it
absorbs into the spinal fluid.

Hide details for General InformationGeneral Information

Disease Group:Blood And Marrow Transplantation; Brain; Pediatrics
Phase of Study:Phase II
Treatment Agents:13-Cis Retinoic Acid
Carboplatin
Temozolomide
Thiotepa
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:The subject will be hospitalized one or two nights during the apheresis process
(if requires a femoral catheter). During the autologous BMT - approximately
3-4 weeks. Outpatient - must remain in the area for days after stem cell
infusion
Supported By:Pediatric Blood and Marrow Transplant Consortium
Return Visit:Twice weekly for up to 2 months post transplant
Home Care:There is a possible need for IV fluids and antibiotics at home.

Subject will receive the 13-cis-retinoic acid by mouth twice a day. It is given
for 14 days followed by a 14 day rest period. Cycle is given 6 times for a
total of 6 months of treatment.


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Laura L. Worth
Dept:Pediatrics
For Clinical Trial Enrollment:713-792-6620
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults