| Eligibility |
Inclusion Criteria:
- Age: Patients must be < 21 years of age inclusive at the time of enrollment on this
protocol.
- Histologic Diagnosis: Histologically proven, primary brain tumor that is recurrent or
progressive and refractory (nonresponsive) to standard, accepted therapy. A
histopathologic diagnosis from either the initial presentation or at the time of
recurrence is required for all subjects, except for diffuse intrinsic pontine glioma
(DIPG).
- Measurable Disease: Patients must have radiographically documented measurable tumor as
assessed by RANO or RAPNO criteria.
- Cranial and Spinal MRI: To document the degree of residual tumor, all patients must
have an MRI of the brain with and without gadolinium performed within 2 weeks prior to
study enrollment. For patients who undergo a tumor debulking surgery at the time of
recurrence/progression, the following must be obtained:
- Cranial pre-operative MRI scan with and without contrast.
- Cranial post-operative MRI scan with and without contrast within 28 days following
surgery. If possible, post-operative MRI should be performed within 48 hours of
surgery, prior to the onset of edema or post-operative surgical enhancement, which can
make measurements of residual tumor difficult.
- Performance Level: Patients must have a performance status of > 50. Use Karnofsky
score for patients > 16 years of age and Lansky score for patients = 16 years of age.
- Life Expectancy: Patients must have a life expectancy of > 8 weeks.
- Prior Therapy: Patients must have fully recovered from the acute toxic effects of all
prior chemotherapy, immunotherapy, biologic therapy, or radiotherapy prior to entering
this study
- Growth factor(s): Must not have received within 1 week prior to entry onto this study.
- Other anti-cancer or experimental agents or therapies are not permitted. Homeopathic
medicines are not permitted. Multivitamins are permitted.
- Organ Function Requirements: Adequate bone marrow, renal, liver, pulmonary, and
central nervous system function
- All patients and/or their parents or legal guardians must sign a written informed
consent.
- In the investigator's opinion, patients must have the ability to adhere to or tolerate
the dietary protocol.
- Patients must be able to eat by mouth or must be willing to have a nasogastric tube
(NGT) if gastrostomy tube is not already present.
Exclusion Criteria:
- Pregnancy
- Pregnant or breastfeeding. Female patients of childbearing potential must have
negative pregnancy test result within the previous 14 days..
- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation.
- Other Exclusionary Criteria: Disorder of B-oxidation, as measured by plasma
aceyl-carnitine, Uncontrolled infection, History of nephrolithiasis, Diagnosis of
diabetes mellitus that is being treated by medication.
- The following medications are excluded: Steroids: Therapeutic systemic doses of
steroids must be stopped greater than 2 weeks prior to admission to the hospital to
start the diet. A steroid washout of 1 week is acceptable for patients with DIPG.
Concomitant chemotherapy drugs and homeopathic drugs are not permitted.
|
