Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors

Completed · Phase 2

Conditions studied: Brain Tumors

In brief

The purpose of this study is to: Find out how safe and effective (by monitoring the good and/or bad effects) treatment with high dose temozolomide, thiotepa and carboplatin with stem cell rescue followed by 13-cis-retinoic acid has on children and adolescents with recurrent/refractory brain tumors Find out how the body uses 13-cis-retinoic acid by studying the your blood levels and proteins in the blood that break down the 13-cis-retinoic acid Determine how well 13-cis-retinoic acid penetrates into the spinal fluid.

Key facts

Study ID

NCT00528437

Run by

NYU Langone Health

People needed

46

Starts

2005-10-01

Expected to finish

2017-12-30

Last updated by the study team

2021-07-08

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with recurrent or refractory medulloblastoma/PNET, CNS germ cell tumors, ependymomas, AT/RT, high grade glioma and other malignant brain tumors. Brainstem gliomas are eligible if residual disease is < 1.5cc and if the patient is off decadron.
• Patients must have recurrent or refractory disease following at least one prior course of therapy and must have minimal residual disease defined as < 1.5 cm2 of enhancement. Patients with + CSF cytology, linear or fine nodular leptomeningeal disease are eligible.
• Adequate hematologic, renal, liver, and cardiac function as demonstrated by laboratory values performed within 21 days, inclusive, prior to administration of temozolomide.
• Patients must have an adequate number of autologous stem cells available defined as a minimum of 2 x 106 CD 34+ cells/kg and preferably at least 5 x 106 CD 34+ cells/kg.

You may not qualify if…

• Previous myeloablative therapy
• Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
• Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin. Patients with prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Emory University — Atlanta, Georgia, United States
• Hawaii Pacific Health — Lihue, Hawaii, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Children's Hospital and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Steven and Alexandra Cohen Children's Medical Center of New York- North Shore LIJ — New Hyde Park, New York, United States
• NYU Hassenfeld Center — New York, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical Univ. of South Carolina — Charleston, South Carolina, United States
• Vanderbilt Univ. — Nashville, Tennessee, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• MD Anderson Cancer Center (MDACC) — Houston, Texas, United States
• Virginia Commonwealth Univ. — Richmond, Virginia, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.