Patient has an extensively disseminated primary glioblastoma
Patients with biopsy proven high-grade glioma (excluding glioblastoma multiforme [GBM]) and a gross total resection and patients with non-disseminated atypical teratoid rhabdoid (ATRT) patients may also be included
Has known glioblastoma multiforme of the brainstem
Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme), established by biopsy or resection not more than months prior to registration
Patients must have histologically proven glioblastoma multiforme (GBM) or gliosarcoma (GS)
Histologically confirmed primary glioblastoma multiforme (GBM)
Patients must have newly diagnosed (i.e., within weeks), histologically or cytologically confirmed glioblastoma multiforme
Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma
Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS); this includes treatment-naive patients with prior tissue diagnoses of lower grade gliomas that have been upgraded to GBM after repeat resection
Patients must have recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma
Histologically proven intracranial Glioblastoma Multiforme (GBM) with diagnosis established by biopsy or resection within weeks prior to enrollment.
Measurable disease per RECIST v. for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
Subjects with Glioblastoma multiforme (GBM) do not have to have objectively measurable disease at entry.
For glioblastoma multiforme (GBM-) cohort:
Any recurrence of a glioblastoma multiforme
Patients must have newly diagnosed (i.e., within weeks), histologically or cytologically confirmed glioblastoma multiforme
Part C: Glioblastoma multiforme that has progressed or recurred after radiotherapy and/or chemotherapy
For Dose Confirmation (Part C): Have glioblastoma multiforme that is radiographically or clinically unstable less than days prior to receiving study drug, regardless of whether they are receiving corticosteroids
Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS); this includes treatment-naive patients with prior tissue diagnosis of lower grade gliomas that have been upgraded after repeat resection
Histopathologically confirmed newly diagnosed glioblastoma multiforme; diagnosis must be made by surgical biopsy or excision
Patients with glioblastoma multiforme or gliosarcoma
Histologically confirmed glioblastoma multiforme or gliosarcoma
Patient with an extensively disseminated primary glioblastoma.
Patient has an extensively disseminated primary glioblastoma.
Glioblastoma Multiforme (GBM)
Histological confirmation of glioblastoma multiforme (grade astrocytoma) as determined by pre-registration central pathology review; note: gliosarcomas and other grade astrocytoma variants (e.g., giant cell) are eligible; glioblastoma (GBM) with oligodendroglial features are NOT PERMITTED in this study if they are pq co-deleted; sites submitting GBM with oligodendroglial features will be asked to provide results of p/q co-deletion status (Phase II)
Up to patients with recurrent/relapsed glioblastoma multiforme (GBM/AnaA) or with grade anaplastic astrocytomas that with a history of progression or recurrence following radiotherapy and an alkylating agent (e.g. temozolomide) Patients with other disease types may be enrolled into the expansion phase upon approval of the Sponsor.
Diagnoses excluded include: glioblastoma multiforme, gliosarcoma, diffuse pontine glioma, or other tumors presumed to have expected median survival per the investigators of less than year
Patients with newly diagnosed glioblastoma multiforme (GBM) and one of the following options:\r\n* Eligible for surgery after the last research scan\r\n* Significant residual disease after initial surgery\r\n** The principal investigator or co-PI must review MRI and CT findings and agree with the presence of significant residual disease\r\n* Treatment (non-surgical) naive
Patients with glioblastoma multiforme