Title (COG ACNS0332) Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
Principal Investigator Martin Brecher, MD
Study Number 111007
Summary The goal of this study is to determine whether radiosensitization with carboplatin or the addition of Isotretinion to maintenance therapy will improve cure rates for children with other than average-risk medulloblastoma/PNET. All patients will receive standard therapy consisting of surgery, radiation therapy and chemotherapy. Subsets of patients will be randomly assigned to receive carboplatin radiosensitization, Isotretinoin during maintenance, both or neither. Carboplatin has activity as a single agent against medulloblastoma and it has been shown to enhance radiation-induced tumor cell kill.
- Age greater than or equal to 3 or less than 22 years at time of diagnosis
- Newly diagnosed, previously untreated Medulloblastoma or supratentorial PNET.
- A pre-operative MRI scan of brain with and without contrast is required. Spinal MRI with and without gadolinium is required within 10 days of surgery if done preop or within 28 days if done post-op.
- Lumbar CSF cytology exam must be obtained pre-op or within 31 days following surgery.
- Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients <= 16 years of age and life expectancy > 8 weeks.
- No previous chemotherapy or radiation therapy
- Patients taking Accutane (Isotretinoin) for acne must discontinue use prior to enrollment
- Adequate organ function requirements, including renal, liver and bone marrow
- Female patients who are post menarchal must have a negative pregnancy test. Lactating female patients must agree not to breastfeed while on this trial. Males or females of reproductive potential may not participate unless they agree to use an effective contraceptive method.