Study on Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma Multiforme (GBM)

Sponsor: Northwell Health

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03213002

Provider View

This clinical trial is testing the safety and effectiveness of adding the drug capecitabine to the standard treatment of temozolomide for patients with newly diagnosed glioblastoma multiforme (GBM), a type of brain cancer.

Patient Parameters

Program Overview

The aim of this study is to see if taking capecitabine along with temozolomide can help treat newly diagnosed glioblastoma multiforme (GBM) more effectively. Capecitabine is a chemotherapy drug usually used for other cancers, and this study will test if it can be safely added to the standard treatment of temozolomide, which is taken after radiation therapy. Researchers want to find out if this combination can help patients respond to treatment for a longer time compared to using temozolomide alone.

Description

Glioblastoma multiforme (GBM) is a common and aggressive type of brain cancer. Although it is rare, there is currently no cure, and the outlook for patients is generally poor. The standard treatment involves surgery to remove the tumor, followed by radiation and chemotherapy with temozolomide. This approach is known as the Stupp protocol. After radiation, patients take temozolomide for five days every 28 days for at least six months. However, more treatments are needed to improve survival and quality of life for these patients. This study is exploring whether adding capecitabine to the standard treatment can enhance its effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent.
  • Diagnosed with newly diagnosed glioblastoma multiforme (GBM).
  • Completed the initial 6-week chemo-radiation treatment and not yet started the maintenance phase of temozolomide.
  • Agree to use effective contraception during treatment and for 2 months after, if able to have children.
  • Life expectancy of more than 3 months.
  • Aged between 18 and 74 years.
  • Performance status score of 70 or higher, meaning able to care for oneself with some assistance.
  • Able to swallow pills and capsules.
  • Can tolerate oral chemotherapy without severe allergies or side effects.
  • Have adequate bone marrow, liver, and kidney function before starting therapy.

Exclusion Criteria

  • Previous treatment with capecitabine or temozolomide for other cancers.
  • Previous chemotherapy for newly diagnosed GBM, except temozolomide during radiation.
  • History of severe allergic reactions to capecitabine, 5-FU, or temozolomide.
  • Serious medical or psychiatric conditions that prevent understanding or receiving treatment.
  • Other cancers in the last 5 years, except for certain treated skin cancers.
  • Performance status score below 70.
  • Unable to swallow pills and capsules.
  • Currently receiving other chemotherapy or treatments for active disease.
  • Taking medications that interact with capecitabine, such as Coumadin or phenytoin.
  • History of heart disease without cardiology evaluation for capecitabine tolerance.
  • Kidney or liver problems.
  • Blood clotting disorders.
  • Pregnant or breastfeeding women.

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