Clinical Trial Details
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NCT00983398 : Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors
PhasePhase 1/Phase 2
AgesMin: 1 Year Max: 45 Years
Inclusion Criteria:

- Subjects with histologically confirmed CNS embryonal tumor (primitive neuroectodermal
tumor [PNET], medulloblastoma, atypical teratoid rhabdoid tumor [ATRT],
medulloepithelioma, pineoblastoma or ependymoblastoma), or germ cell tumor, are
eligible; tumors must be relapsed or refractory to first-line therapy; diagnosis will
be made on the basis of computed tomography (CT)-assisted or stereotactic biopsy, open
biopsy, surgical resection, cerebrospinal fluid (CSF) cytology, or elevated tumor

- Subjects under the age of 18 must have had prior therapy according to the best
available therapy as determined by their primary brain tumor specialist (to include
oncology, neurosurgery and/or radiation oncology) including systemic and/or cranial or
spinal radiation or chemotherapy; subjects over the age of 18 may be enrolled as part
of first-line treatment; those subjects who enroll as first-line treatment will not be
restricted from traditional treatments in the future; at least 14 days must have
elapsed since completion of cranial radiotherapy and 28 days since completion of
chemotherapy; at least 28 days must have elapsed since completion of total spine

- Subjects with no previous radiotherapy treatment must have a consultation with a
radiation oncologist or providers must have a discussion in the context of
Neuro-Oncology Tumor Board within 60 days prior to start of IA/BBBD chemotherapy to
determine the need for radiotherapy prior to or after IA/BBBD

- Glomerular filtration rate (GFR) or creatinine clearance (CrCl) (24 hour urine)
greater than 30 ml/min corrected for body surface area

- Absolute granulocyte count >= 1.0 x 10^3/mm^3

- Platelets >= 100 x 10^3/mm^3

- Creatinine < 1.5

- Total bilirubin < 2.0 mg/dl

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limits
of normal

- Subject's Karnofsky performance status (KPS) must be >= 50% (Eastern Cooperative
Oncology Group [ECOG] performance score < 3); the Lansky scale will be used for
subjects less than 16 years of age and must be >= 50%

- Subjects or their legal guardian must sign a written informed consent in accordance
with institutional guidelines

- Sexually active women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
treatment and for the duration of study treatment; should a female become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately

- For the phase II portion of the study, subjects must have disease that is evaluable
for response; subjects who have had radiation to all sites of disease are not eligible
unless there is imaging evidence of active tumor, ie: increased blood volume

Exclusion Criteria:

- Subjects with radiographic signs of excessive intracranial mass effect with associated
rapid neurologic deterioration and/or spinal cord block

- Subjects at significant risk with general anesthesia

- Subjects with uncontrolled (over the last 30 days) clinically significant confounding
medical conditions

- Subject is pregnant or is lactating

- Subjects who have contraindications to carboplatin, melphalan, or STS
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