Phase 2
N=160
Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
Glioblastoma Multiforme · Glioma · Gliosarcoma · Malignant Brain Tumor
Bottom Line
View on ClinicalTrials.gov: NCT02052648 ↗Enrolled (actual)
160
Serious AEs
33.3%
Results posted
Mar 2024
Primary outcome: Primary: Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Indoximod (Drug); Temozolomide (Drug); Bevacizumab (Drug); Stereotactic Radiation (Radiation)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- NewLink Genetics Corporation
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects |
0; 0; 0 | — |
| PRIMARY Phase 2: Number of Phase 1 Participants With Efficacy Outcomes |
18.6; 3.9; 22.9 | — |
| SECONDARY Overall Response Rate for Phase 2 Participants |
5.2; 0; 7.7 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
3; 3; 6; 72; 27; 39 | — |
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.
Eligibility Criteria
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.
- Patients will be eligible if the original histology was lower grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made.
- 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
Data sourced from ClinicalTrials.gov (NCT02052648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.