Study on WP1066 and Radiation Therapy for Newly Diagnosed Glioblastoma

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05879250

Provider View

This clinical trial is exploring the effectiveness of combining WP1066, a drug that targets tumor growth pathways, with radiation therapy to treat newly diagnosed glioblastoma, a challenging brain cancer. The study aims to see if this combination can stop the tumor from growing and improve patient survival.

Patient Parameters

Program Overview

This phase II study is testing how well WP1066, a drug that targets a specific pathway in tumor cells, works with radiation therapy to treat newly diagnosed glioblastoma. Glioblastoma is a tough cancer to treat because its cells vary widely and are influenced by many factors. WP1066 targets the STAT3 pathway, which helps tumors grow and evade the immune system. Radiation therapy helps stop glioblastoma from growing. The study aims to see if combining WP1066 with radiation can prevent tumor growth and extend survival.

Description

The main goals of this study are to see how long patients with a specific type of glioblastoma (MGMT-unmethylated) can live without the cancer getting worse when treated with WP1066 and radiation therapy. Researchers also want to understand how this treatment changes the tumor environment.

Secondary goals include measuring overall survival, response rates, and how long it takes for the disease to progress. The study will also look at immune responses and the safety of WP1066 with radiation therapy.

An exploratory goal is to use advanced imaging techniques to analyze brain tumors before surgery and compare them with data from the tumor itself.

Patients are divided into two groups:

  • Cohort I: Patients whose tumor was completely removed during initial surgery will take WP1066 orally for 6 weeks during radiation therapy, followed by 12 cycles of WP1066 over 28 days each. They will have regular MRI scans and blood tests.

  • Cohort II: Patients whose tumor was not fully removed will take WP1066 for 6 weeks during radiation therapy. They may have surgery or a biopsy if needed, followed by 12 cycles of WP1066. They will also have regular MRI scans and blood tests.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed glioblastoma confirmed by lab tests.
  • Tumor must be IDH wild-type and MGMT unmethylated.
  • For Cohort 1: Tumor was completely removed during surgery.
  • For Cohort 2: Tumor was not fully removed and is measurable on MRI.
  • Must start trial therapy within 8 weeks of initial brain surgery.
  • Age 18 or older.
  • Good overall health with a performance score of 60% or higher.
  • Adequate blood cell counts and organ function based on specific tests.
  • Willing to undergo MRI scans with contrast.
  • Agree to use effective birth control during and after the study.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Received investigational drugs within 2 weeks before the study.
  • Previous gene therapy, bevacizumab, or Gliadel treatment.
  • Currently using Optune or other active cancer therapies that cannot be stopped.
  • Allergic to WP1066 or similar compounds.
  • HIV-positive patients on antiretroviral therapy.
  • Taking drugs that interact with WP1066 within 2 weeks before the study.
  • Uncontrolled seizures or large brain lesions.
  • History of brain hemorrhage or uncontrolled illness.
  • Pregnant or breastfeeding women.
  • Unable to comply with study requirements due to other health conditions.

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