Phase 2
N=46
Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00528437 ↗Enrolled (actual)
46
Serious AEs
—
Results posted
Jul 2021
Primary outcome: Primary: Event-free Survival (EFS)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival (EFS) |
— | — |
| PRIMARY Overall Survival (OS) |
— | — |
| SECONDARY Toxicity of of 13-cis-retinoic Acid |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00528437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.