Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Oligodendroglioma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Abemaciclib 200mg tablet PO twice daily administered on 28-day cycles Subjects remain on treatment until tumor progression or unacceptable toxicity.

Subjects will be treated with abemaciclib 200mg by mouth once every 12 hours. Dosing will be continuous and administered on a 28-day cycle

Abemaciclib 200 MG

Stephen Bagley, MD

This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma

Primary Objective:

• To determine the efficacy of abemaciclib for recurrent oligodendroglioma, as measured by the estimated proportion of patients alive without disease progression at 6 months from study enrollment (PFS-6)

Secondary Objectives:

* To evaluate the safety and tolerability of abemaciclib in recurrent oligodendroglioma
* To estimate the objective radiographic response rate (ORR) associated with abemaciclib in recurrent oligodendroglioma
* To determine the median progression-free survival (PFS) and overall survival (OS) of patients with recurrent oligodendroglioma treated with abemaciclib
* To determine ORR, PFS, and OS in the subgroup of recurrent oligodendroglioma patients with tumor CIC gene mutations

Exploratory Objectives:

* To measure pharmacodynamic markers of abemaciclib activity on oligodendroglial tumor cells
* To identify pre-treatment tumor characteristics that are associated with response to abemaciclib recurrent oligodendroglioma

This is an open-label, single-institution, single-arm phase II study of the efficacy and safety of abemaciclib in patients with recurrent oligodendroglioma.

Abemaciclib in Patients With Oligodendroglioma

A Single-Arm, Open-label, Phase II Study Evaluating the Efficacy and Safety of Abemaciclib in Patients With Recurrent Oligodendroglioma

Assessed as a) Tumor progression (as measured by modified RANO criteria) or death due to disease or toxicity; OR b) alive without tumor progression

Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0

measured by modified Response Assessment in Neuro-Oncology (RANO) criteria.

defined as the time from date of enrollment until the earliest date of disease progression (as determined by modified RANO criteria) or death due to any cause

defined as the time from date of enrollment until death from any cause

Abramson Cancer Center at Penn Medicine

University of Pennsylvania

Stephen Bagley, MD, MSCE

Assistant Professor of Medicine

Astrocytoma

Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity.

Intensity modulated RT (IMRT) using single or two arc therapy will be used for RT delivery.

temporally-modulated pulsed radiotherapy (TMPRT)

Jiayi Huang, M.D.

Shahed Badiyan, M.D.

Stephanie Perkins, M.D.

Michael Prusator, Ph.D.

Milan Chheda, M.D.

Tanner Johanns, M.D., Ph.D.

George Ansstas, M.D.

Omar Butt, M.D., Ph.D.

Chris Abraham, M.D.

Yi Huang, M.S.

Clifford Robinson, M.D.

Nikhil Rammahon, M.D. Ph.D.

This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. This technique may improve efficacy while reducing toxicity and improving patient quality of life.

Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas

A Pilot Study of Temporally-modulated Pulsed Radiation Therapy to Reirradiate Recurrent IDH-mutant Gliomas After Prior External Beam Radiation Therapy

Blood will be collected before the start of TMPRT and at week 6 of radiation therapy to assess for changes in myeloid cells.

Blood will be collected before the start of TMPRT and at week 6 of radiation therapy to assess for changes in circulating T-cells.

Intolerable toxicities are defined as grade 3 or higher central nervous system (CNS) adverse events at least possibly related to radiation as graded by the Common Terminology Criteria for Adverse Events v5.0 with the exception of grade 3 fatigue, headache, nausea, and vomiting. Any serious adverse event leading to discontinuation of TMPRT that is at least possibly related will be considered an intolerable toxicity.

Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

The MDASI-BT consists of 23 symptom questions asking the patient to rate the severity of their symptoms in the last 24 hours. The range is an 11-point scale (0 to 10), with 0 being "not present" and 10 being "as bad as you can imagine". The symptom composite score is the average of the symptoms items, and the score ranges from 0 to 23 with a higher score indicating more severe symptoms. Symptom burden deterioration is defined as an increase of more than 1 point from baseline on the composite symptom scale.

The MDASI-BT consists of 6 interference questions asking the participant to rate how their symptoms interfered with how they felt and functioned in the last 24 hours. The range is an 11-point scale (0 to 10), with 0 being "did not interfere" and 10 being "interfered completely". The interference composite score is the average of the 6 items on interferences, with a higher score indicating more interference. Interference deterioration is defined as an increase of more than 1 point from the baseline on the interference score.

The LASA is a single-item questionnaire that asks the participants to rate their overall quality of life. The LASA scale runs from 0 (as bad as it can be) to 10 (as good as it can be).

PFS is defined as the time from start of treatment until time of disease progression or death from any cause. Progression will be evaluated per standard clinical care based on the Response Assessment in Neuro-Oncology (RANO) criteria for low-grade glioma (van dent Bent et al., 2011).

OS is defined as the time from start of treatment until the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Abemaciclib in Patients With Oligodendroglioma	NCT03969706	Oligodendroglio...	Abemaciclib 200...	18 Years -	Abramson Cancer Center at Penn Medicine
Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas	NCT05393258	Astrocytoma Oligodendroglio... Glioma, Maligna...	temporally-modu...	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for oligodendroglioma, adult