Protocol Summary

Protocol No.: OCR13764

Sponsor Protocol No.: SJMB12

Study Title
A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Principal Investigator(s)
Indelicato, Daniel

Objective
This study is being conducted to find out if participants with certain types of medulloblastoma can be treated with a lower dose of radiation to the brain and spine and a lower dose of the chemotherapy drug cyclophosphamide. We hope to learn whether adding new chemotherapy agents to the standard chemotherapy will improve the survival for intermediate and high risk tumors.

Description
Treatment of children 3-21 years for newly diagnosed medulloblastoma with clinical and molecular risk directed therapy. Therapy includes reduced dose cyclophosphamide, reduced dose radiation therapy for low risk medulloblastoma, and use of novel therapies targeted toward the specific molecular subgroups of the disease.

Phase: Phase II

Age Group: Children

Scope: National

Treatment
Low risk:
Participants will receive a total of 15 CGE to the brain and spinal cord with a 51 CGE boost to the tumor region itself.

Standard risk and intermediate risk:
Participants will receive 23.4 CGE to the brain and spinal cord with a 54 CGE boost to the tumor region itself.

High risk:
Participants will receive 36-39.6 CGE to the brain and spinal cord with a 54 CGE boost to the tumor region itself

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 3 to 21 year-old at the time of diagnosis.
2. Medulloblastoma or medulloblastoma variants including posterior fossa PNET as documented by an institutional pathologist.
3. No previous radiotherapy, chemotherapy or other brain tumor directed therapy other than corticosteroid therapy and surgery.
4. Patients must begin treatment as outlined in the protocol within 36 days of definitive surgery (day of surgery is day 0; definitive surgery includes second surgeries to resect residual tumor).
5. Adequate performance status: children = 30; children >= 10-Karnofsky >= 30 (except for posterior fossa syndrome).
6. Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants > 10 years of age or post-menarche must have a negative serum or urine pregnancy test prior to enrollment.
7. Biological parent(s) of participant (child) enrolling on this protocol. These parents will be assigned to cohort P. The exclusion criteria below do not apply to this cohort.

EXCLUSION CRITERIA:
1. CNS embryonal tumor other than medulloblastoma or PNET in the posterior fossa, for example, patients with diagnosis of Atypical Teratoid / Rhabdoid Tumor (ATRT), supratentorial PNET, pineoblastoma, ependymoblastoma, ETANTR are excluded.
2. Research participants with other clinically significant medical disorders that could compromise their ability to tolerate protocol therapy or would interfere with the study procedures or results history.
3. Participants in the exercise intervention portion of the study must meet all criteria below:
- Must be > 5 years at the time of enrollment
- Must have no congenital heart disease
- Must be capable of performing the exercise intervention at the time of baseline assessment as determined by the treating physician.
4. Participants in the cognitive remediation intervention portion of the study must meet all criteria below:
- Completed protocol-directed radiation therapy
- >= 5 years at the time of remediation intervention consent
- English as primary language and training aide who speaks English available to participate in required sessions
- No significant cognitive impairment operationalized as either an IQ - No major sensory or motor impairment that would preclude valid cognitive testing (e.g., unresolved posterior fossa syndrome, blindness, poorly controlled seizures/photosensitive epilepsy, psychosis) or a major psychological condition that would preclude completion of the intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms).

Applicable Disease Sites
Pediatric (Childhood) Cancer

Participating Institutions
UF Gainesville
UF Jacksonville

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT01878617