Clinical Trial Details
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NCT00528437 : Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
PhasePhase 2
AgesMin: 6 Months Max: 21 Years
Inclusion Criteria:

1. 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

2. 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.

3. Adequate hematologic, renal, liver, and cardiac function as demonstrated by
laboratory values performed within 21 days, inclusive, prior to administration of

4. 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.

Exclusion Criteria:

1. Previous myeloablative therapy

2. Frequent vomiting or medical condition that could interfere with oral medication
intake (e.g., partial bowel obstruction)

3. 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.
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