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Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

A Phase I/II Study of the Combination of Indoximod and Temozolomide for Adult Patients With Temozolomide-Refractory Primary Malignant Brain Tumors

NCT02052648•NewLink Genetics Corporation

View on ClinicalTrials.gov

Summary

In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies.

Detailed Description

The aim of this study is to identify the safety profile and the recommended dose for phase 2 study of the combination of indoximod (portion 1, phase 1b study). Investigators will then evaluate the tolerability and the preliminary activity in patients with recurrent GBM in three different situations: * Combination of indoximod and temozolomide (bevacizumab-naive patients) * Combination of indoximod and temozolomide in patients currently receiving or having received and failed bevacizumab. * Combination of indoximod and temozolomide with stereotactic radiation. Ancillary studies will be conducted to assess the correlation between intra-tumoral IDO expression or serum biomarkers (immune monitoring) and treatment efficacy. If the current study shows an acceptable safety profile and suggests preliminary evidence of activity, this will provide the justification for subsequent randomized phase 2 studies in refractory glioblastoma multiforme (GBM).

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven intracranial glioblastoma multiforme (WHO grade IV glioma) or gliosarcoma. In addition, the Phase 1b cohort will include patients with progressive WHO grade III glioma.
•Unequivocal radiographic evidence for tumor progression by MRI. It is understood that some patients may be resected prior to enrolling onto protocol
•Patients must have completed a course of radiation therapy and at least 2 adjuvant cycles of temozolomide for the phase 2 component.
•Patients enrolling onto Cohort 2b who have been taken off bevacizumab must have had at least a 28 day washout from any previous administration of bevacizumab. It is preferred that patients who fail bevacizumab prior to trial entry remain on bevacizumab in the trial.
•Prior temozolomide is not required for the phase 1 component; prior radiation is required for the phase 1 arm.
•Patients must be on a steroid dose less than or equal to 2 mg of dexamethasone daily (or equivalent), and this dose must not have increased for at least 14 days prior to obtaining the enrollment.
•ECOG performance status ≤1 or Karnofsky ≥70%.
•Age between 16
•Must be 28 days from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
•Must be 14 days from administration of non-cytotoxic agents (e.g., bevacizumab (except COHORT 2b), interferon, tamoxifen, thalidomide, cis-retinoic acid, tyrosine kinase inhibitor, etc.).

Exclusion Criteria

•Prior invasive malignancy that is not low-grade glioma, high-grade glioma, glioblastoma, or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years.
•Patients on the phase 2 portion of the study may not have more than 2 prior regimens for recurrent disease for glioblastoma/gliosarcoma. Patients on the phase 1 portion of the study may not have had more than 3 prior regimens.
•Systemic corticosteroid therapy \> 2 mg of dexamethasone daily (or equivalent) at study enrollment.
•Active or history of autoimmune disease

Locations (17)

Eden Medical Center

Castro Valley, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

UC Irvine Chao Family Comprehensive Cancer Center

Orange, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University Cancer and Blood Center

Athens, Georgia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kentucy

Lexington, Kentucky, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

April 18, 2018

Completion Date

June 20, 2019

Last Updated

March 27, 2024

Enrollment

160

ACTUAL participants

Conditions

Glioblastoma MultiformeGliomaGliosarcomaMalignant Brain Tumor

Interventions

Indoximod

DRUG

Temozolomide

DRUG

Bevacizumab

DRUG

Stereotactic Radiation

RADIATION

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma