Pharmacological Study for Grade III Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Grade III Glioma+10 MorePharmacological Study - Other
Eligibility
12 - 21
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies selinexor to learn if it can help to shrink tumors in young patients with solid tumors or CNS tumors.

Eligible Conditions
  • Grade III Glioma
  • Malignant Glioma
  • Refractory Primary Central Nervous System Neoplasm
  • Grade 3 Glioma
  • Refractory Malignant Solid Tumor
  • Brain Tumor
  • Refractory Lymphomas
  • Childhood Brain Tumor
  • Recurrent Childhood Glioblastoma
  • Recurrent Lymphoma
  • Recurrent Malignant Solid Tumor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 5 Secondary · Reporting Duration: Up to 2 years

Up to 2 days
Area under the drug concentration curve of selinexor
Clearance of selinexor
Half-life of selinexor
Maximum serum concentration of selinexor
Minimum serum concentration of selinexor
Up to 2 years
Antitumor effect of selinexor
Frequency of adverse events of selinexor
Radiographic response of selinexor in HGG patients
Up to 28 days
Frequency of dose limiting toxicities of selinexor
Pharmacodynamics of selinexor
Pharmacodynamics of selinexor in high-grade glioma (HGG) patients
Up to 6 months
Progression-free survival of selinexor in HGG patients

Trial Safety

Trial Design

1 Treatment Group

Treatment (selinexor)
1 of 1

Experimental Treatment

68 Total Participants · 1 Treatment Group

Primary Treatment: Pharmacological Study · No Placebo Group · Phase 1

Treatment (selinexor)Experimental Group · 2 Interventions: Pharmacological Study, Selinexor · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,099 Previous Clinical Trials
41,145,719 Total Patients Enrolled
Children's Oncology GroupLead Sponsor
450 Previous Clinical Trials
236,777 Total Patients Enrolled
Julia Glade-BenderPrincipal InvestigatorCOG Phase I Consortium
2 Previous Clinical Trials
104 Total Patients Enrolled

Eligibility Criteria

Age 12 - 21 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with high grade gliomas that have come back or that are resistant to treatment, including those that have spread to other parts of the body, do not need surgery in order to be treated; and these patients must have had a diagnosis of cancer confirmed by a biopsy.
People with a type of brain tumor that keeps coming back or is very hard to treat (grade III or IV), and who need surgery, may be able to receive 2 doses of selinexor before the surgery
The Karnofsky performance score is >= 50% for patients who are >= 16 years of age, and the Lansky performance score is >= 50 for patients who are =< 16 years of age
Patients with 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)) are eligible for the study.
To be eligible for clinical study participation, a patient's body surface area (BSA) must be greater than or equal to 0.84 square meters.
This clinical trial is for patients with brain metastases, who have measurable disease on imaging.
and a life expectancy of at least 3 months This means that patients must have either a measurable or evaluable disease and a life expectancy of at least 3 months.
There is no cure for the patient's disease, and the available therapies do not improve survival or quality of life.
Patients must have fully recovered from their acute toxic effects from all prior anti-cancer therapy
This means that a person should wait at least 21 days after their last dose of chemotherapy before they donate blood

Who else is applying?

What state do they live in?
California100.0%
How old are they?
65+100.0%
What site did they apply to?
UCSF Medical Center-Mission Bay100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%