Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid Tumors, CNS Tumors, Lymphoma, or T-Cell Leukemia

Stopped early · Phase 1

Conditions studied: Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Central Nervous System Choriocarcinoma, 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 Infratentorial Ependymoma, Childhood Medulloepithelioma, Childhood Mixed Glioma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Gonadotroph Adenoma, Pituitary Basophilic Adenoma, Pituitary Chromophobe Adenoma, Pituitary Eosinophilic Adenoma, Prolactin Secreting Adenoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, 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 Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Spinal Cord Neoplasm, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent Pituitary Tumor, Recurrent/Refractory Childhood Hodgkin Lymphoma, T-cell Childhood Acute Lymphoblastic Leukemia, T-cell Large Granular Lymphocyte Leukemia, TSH Secreting Adenoma, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

This phase I/II clinical trial is studying the side effects and best dose of gamma-secretase inhibitor RO4929097 and to see how well it works in treating young patients with relapsed or refractory solid tumors, CNS tumors, lymphoma, or T-cell leukemia. Gamma-secretase inhibitor RO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01088763

Run by

National Cancer Institute (NCI)

People needed

129

Starts

2010-03-01

Expected to finish

2011-05-01

Last updated by the study team

2014-11-05

Who can join

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

You may qualify if…

• Histologically confirmed malignancy (at diagnosis or relapse)
• Biopsy not required for intrinsic brain stem tumors or optic pathway gliomas
• No B-cell precursor acute lymphoblastic lymphoma (ALL) or acute myeloid leukemia
• No T-cell leukemia with CNS3 disease
• Measurable or evaluable disease
• Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• Neurologic deficits in patients with CNS tumors must have been relatively stable for 1 week
• No active CNS leukemia
• Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) or Lansky PS 50-100% (for patients ≤ 16 years of age)
• Patients who are unable to walk because of paralysis,but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the PS
• Patients with solid tumors without bone marrow involvement must meet the following criteria:
• Peripheral ANC ≥ 1,000/mm\^3
• Platelet count ≥ 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions within the past 7 days)
• Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
• Patients with known bone marrow metastatic disease must meet the above criteria and must not be known to be refractory to red cell or platelet transfusion
• Patients with leukemia must meet the following criteria:
• Platelet count ≥ 20,000/mm\^3 (may receive platelet transfusions)
• Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
• Must not be known to be refractory to RBC or platelet transfusions
• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age/gender as follows:
• ≤ 0.6 mg/dL (patients 1 to < 2 years)
• ≤ 0.8 mg/dL (patients 2 to < 6 years)
• ≤ 1 mg/dL (patients 6 to < 10 years)
• ≤ 1.2 mg/dL (patients 10 to < 13 years)
• ≤ 1.4 mg/dL (female patients ≥ 13 years)

Where it is running

• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Stanford University Hospitals and Clinics — Stanford, California, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, 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

Full record on ClinicalTrials.gov

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