Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Stem Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Infratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Everolimus

Mitogens

Dasatinib

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Tyrosine Kinase Inhibitors

Tyrosine

Dasatinib = 60 mg/m2 orally twice daily

Everolimus = starting dose of 3.0 mg/m2, with titration of dosing after first cycle to keep everolimus trough level of 5-15 ug/ml

Both agents will be taken daily for 28 day cycles. Cycles will be repeated every 28 days and patients may receive up to 24 cycles.

3.0 mg/m2, with titration of dosing after first cycle to keep trough level of 5-15 ug/ml

Carl Koschmann, M.D.

This trial will evaluate the activity of dasatinib in combination with everolimus for children with gliomas harboring PDGFR alterations, including newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) after radiation (stratum A); and recurrent/progressive glioma (grade II-IV, including DIPG) (stratum B).

Study of Dasatinib in Combination With Everolimus for Children and Young Adults With Gliomas Harboring Platelet-Derived Growth Factor Receptor (PDGFR) Alterations

A Phase 2 Study of Dasatinib in Combination With Everolimus for Children With Gliomas Harboring PDGFR Alterations

Percentage of participants without progression, defined as 25% increase in the size of the tumor or appearance of new lesions.

The overall response assessment will take into account response in both target and non-target lesions, as well as the appearance of new lesions. Partial Response (PR) will be defined as ≥50% decrease in size of tumor in comparison to baseline measurements. Complete Response (CR) will be defined as the disappearance of all abnormal signal. This includes return to normal size of the brain stem for brain stem lesions. Reported as percentage of participants with partial or better response at 56 days.

Percentage of patients alive at one year.

Percentage of participants alive at 2 years.

University of Michigan Rogel Cancer Center

Dasatinib+Everolimus

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Trial enrollment was limited due to requirement for patient insurance coverage for all aspects of treatment. Due to limited sample size, full statistical analysis isn't possible. Descriptive results of this cohort compiled with data available from patients treated locally with a similar treatment plan is available in the following publication: Miklja et al, JCI, 2020 \[PMID: 32603316\].

Carl Koschmann, MD

Progression-free Survival in Participants With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)

Progression-free Survival in Participants With Newly Diagnosed High-grade Glioma (HGG)

Overall Response Rate (OR) (Partial Response or Better) in Participants With Refractory or Recurrent Glioma

Overall Survival

Overall Study

Spots Global Cancer Trial Database for Study of Dasatinib in Combination With Everolimus for Children and Young Adults With Gliomas Harboring Platelet-Derived Growth Factor Receptor (PDGFR) Alterations

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial