Part A: Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors
Brain Tumors
Tumors of all locations in the central nervous system, with appropriate histology, are eligible for study; however, patients with intrinsic brainstem tumors of the pons will be excluded from the study; patients with primary spinal cord lesions are allowed; patients with metastatic disease are also allowed
Histologically confirmed Rb1 positive primary recurrent, progressive, or refractory central nervous system tumors; patients with low grade gliomas are excluded
PROCUREMENT EXCLUSION CRITERIA: Patients diagnosed with primary central nervous system (CNS) tumors
Patients diagnosed with primary CNS tumors
Patients with primary CNS tumors are ineligible.
Ocular primary tumors.
Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
PRE-REGISTRATION: Primary tumors of the central nervous system.
Subjects with resected primary tumors who have documented metastases are eligible
Patients with primary CNS tumors are not eligible
* Phase 1 (Part A1) - COMPLETE: Patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma (excluding patients with primary or metastatic central nervous system [CNS] tumors or patients with primary cutaneous ALCL)
Clinically active primary central nervous system tumors or brain metastases with the exception of subjects with glioblastoma multiform that carry ROS1 rearrangement
Primary brain malignant tumors
Patients with primary tumors > 3 cm
Patients with primary brain tumors are excluded; patients with metastatic brain tumors may be enrolled
Patients with a histologically confirmed diagnosis of a primary CNS tumor that is recurrent, progressive or refractory to standard therapy; refractory disease will be defined as the presence of persistent abnormality on conventional magnetic resonance imaging (MRI) imaging that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment; all tumors must have histological verification at either the time of diagnosis or recurrence except for patients with diffuse intrinsic brain stem tumors or optic pathway gliomas; patients with neurofibromatosis type-I (NF-1) associated CNS tumors are eligible if they meet all other eligibility criteria
Patients must have a histologically confirmed solid tumor malignancy at either original diagnosis or relapse for which no curative therapy exists, and which has either recurred or progressed after at least one prior systemic therapy; patients with primary brain tumors, or those with brain metastases at time of potential enrollment, are excluded; additionally, patients with gastrointestinal stomal tumors (GIST), alveolar soft part sarcoma, or dermatofibrosarcoma protuberans are excluded
Phase 1: All solid tumors (measurable or evaluable disease), including primary central nervous system (CNS) tumors; exclusion of hepatoblastoma and lymphomas
Known brain metastases or primary central nervous system tumors with seizures that are not well controlled with standard medical therapy
Patients with primary central nervous system tumors or brain metastases.
Patients with history or known presence of primary central nervous system (CNS) tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded
Primary brain tumors or CNS metastases;
Evidence or history of central nervous system (CNS) disease, including primary brain tumors, seizures disorders, or any brain metastasis
Histologically confirmed solid tumors, including primary brain tumors; in subjects with brain stem or optic gliomas the requirement for histological confirmation may be waived
Patients with history or known presence of primary central nervous system (CNS) tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded
Participants with primary brain tumors or disease metastatic to the brain.
Known primary central nervous system (CNS) tumors or brain metastases
Cohorts 2 & 3 only: Patients with secondary brain tumors must be greater than or equal to 4 weeks from radiotherapy. Patients with progressive secondary brain tumors will not be enrolled under this protocol following the completion of Cohort 3.
Symptomatic primary tumors or metastasis of brain and/or central nervous system that are uncontrolled with antiepileptics and requiring high doses of steroids
Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, or history of central nervous system metastases
Patients with brain tumors
Primary brain tumors
Patients with brain metastases from primary germ cell tumors, small cell carcinoma, unknown primary, or lymphoma
Diagnosis of primary brain tumors
Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptic and requiring high doses of steroids.
Patients presenting with brain tumors will be eligible for this study
Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
Patients with primary CNS tumors and leptomeningeal disease are ineligible.