Study on Gene Therapy, Radiation, and Chemotherapy for Newly Diagnosed Brain Tumors (GBM and AA)

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03603405

Provider View

This clinical trial is testing a new treatment approach that combines gene therapy, a medication called valacyclovir, radiation, and chemotherapy for patients newly diagnosed with certain types of brain tumors, specifically glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA).

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment that combines gene therapy (HSV-tk), valacyclovir, radiation, and chemotherapy for patients with newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA). Researchers will monitor patients' responses through various tests, including neurological exams, imaging, and blood tests. The study will also look at how long it takes for the disease to progress and overall survival rates.

Description

This study is designed to test a new treatment for patients with newly diagnosed brain tumors, specifically glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA). The treatment involves a combination of gene therapy (HSV-tk), a medication called valacyclovir, radiation therapy, and standard chemotherapy.

Patients will undergo various evaluations, including neurological exams, imaging studies, and blood tests, to assess their response to the treatment. The study will also involve genetic testing of tumor tissue to better understand the effects of the treatment. Researchers will monitor any side effects using standard criteria and will track how long it takes for the disease to progress and overall survival rates.

Participants will need to provide blood samples and tumor biopsies as part of the study. They will also need to agree to follow the study procedures and attend regular follow-up visits.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of anaplastic astrocytoma or glioblastoma multiforme without multiple large tumors or brainstem involvement.
  • Life expectancy of at least 12 weeks.
  • Newly diagnosed with anaplastic astrocytoma or glioblastoma, or have had surgery for these tumors but no prior radiation or chemotherapy.
  • Good overall health with an ECOG performance status of 0 or 1.
  • No other active cancers, except for certain skin cancers.
  • May include patients with certain types of brain or spinal cord involvement.
  • Must provide informed consent and agree to study procedures.
  • Women of childbearing potential must have a negative pregnancy test and not be breastfeeding.
  • Must agree to use effective birth control methods.
  • Must have adequate organ function based on specific blood test results.

Exclusion Criteria

  • Previous treatment with certain immune therapies or gene therapies within the last 3 months.
  • Recent chemotherapy, radiation, or investigational drugs within 3 weeks of starting the study.
  • Multiple large tumors or brainstem involvement.
  • Use of immunosuppressive drugs, except for steroids for brain swelling.
  • Certain liver diseases or recent alcohol abuse.
  • Allergies to the study drugs or inability to take oral medications.
  • Active infections or other serious health conditions.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Under 18 years of age.
  • Unable or unwilling to follow the study protocol.

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