Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gl… (NCT02323880) | Clinical Trial Compass
CompletedPhase 1
Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
United States59 participantsStarted 2015-10-30
Plain-language summary
This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system (CNS) tumors that have come back (recurrent) or do not respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Who can participate
Age range12 Months – 21 Years
SexALL
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Inclusion Criteria:
* Patients must have a body surface area (BSA) \>= 0.84 m\^2
* Diagnosis:
* Part A: Patients with recurrent or refractory solid tumors, including lymphoma and CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
* Part B: Patients with recurrent or refractory high grade glioma (World Health Organization \[WHO\] grade III/IV) including disseminated tumors (excluding diffuse intrinsic pontine glioma \[DIPG\]), not requiring surgical resection; patients must have had histologic verification of malignancy at original diagnosis or relapse
* Part C: Patients with recurrent or refractory high grade glioma (WHO grade III/IV) and requiring surgical resection (excluding DIPG and disseminated tumors), who in the opinion of treating physicians, are medically stable to receive 2 doses of selinexor (8-10 days of treatment) before undergoing surgery without compromising the success of the procedure; note that if, in the opinion of treating physicians, current symptoms necessitate surgery before 2 doses will be able to be received, surgery should not be delayed to administer selinexor, and the patient would be ineligible for protocol therapy
* Disease status…
What they're measuring
1
Number of Dose Limiting Toxicities of Selinexor
Timeframe: Up to 28 days
2
Number of Adverse Events of Selinexor
Timeframe: Up to 6 years 11 months
3
Area Under the Drug Concentration Curve of Selinexor