Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors

Completed · Phase 1

Conditions studied: Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Embryonal Tumor, Childhood Central Nervous System Germinoma, Childhood Central Nervous System Mixed Germ Cell Tumor, Childhood Central Nervous System Teratoma, Childhood Central Nervous System Yolk Sac Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Ependymoblastoma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Childhood Infratentorial Ependymoma, Childhood Low-grade Cerebellar Astrocytoma, Childhood Low-grade Cerebral Astrocytoma, Childhood Medulloepithelioma, Childhood Mixed Glioma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Extra-adrenal Paraganglioma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Central Nervous System Embryonal Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Spinal Cord Neoplasm, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma

In brief

This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating young patients with relapsed or refractory primary brain tumors or spinal cord tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug.

Key facts

Study ID

NCT01076530

Run by

National Cancer Institute (NCI)

People needed

27

Starts

2010-02-01

Last updated by the study team

2013-05-03

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed CNS malignancy at original diagnosis or relapse
• Histologic confirmation not required for patients with intrinsic brain stem tumors, optic pathway gliomas, or pineal tumors provided CSF or serum tumor markers, including alpha-fetoprotein orbeta-HCG, are elevated
• Recurrent or refractory spinal cord tumors allowed
• Measurable or evaluable disease
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
• Neurological deficits must have been relatively stable for ≥ 1 week before study entry
• Patients unable to walk due to paralysis, but who are up in a wheelchair, are considered ambulatory for the purpose of assessing performance status
• ANC ≥ 1,000/μL
• Platelet count ≥ 100,000/μL (transfusion independent, defined as no platelet transfusion within the past 7 days)
• Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
• Creatinine clearance or radioisotope GFR ≥ 70mL/min OR maximum serum creatinine based on age and/or gender as follows:
• 0.6 mg/dL (1 year of age)
• 0.8 mg/dL (2 to 5 years of age)
• 1.0 mg/dL (6 to 9 years of age)
• 1.2 mg/dL (10 to 12 years of age)
• 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years of age)
• 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years of age)
• Bilirubin ≤ 1.5 times upper limit of normal
• ALT ≤ 110 U/L
• Serum albumin ≥ 2 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to swallow capsules or liquid

Where it is running

• Childrens Memorial Hospital — Chicago, Illinois, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• University of Minnesota Medical Center-Fairview — Minneapolis, Minnesota, United States
• Oregon Health and Science University — Portland, Oregon, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada
• Hospital Sainte-Justine — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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