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New treatment option for Glioblastoma Multiforme (GBM)
Official title Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
ClinicalTrials.gov ID: NCT03213002
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for glioblastoma multiforme (gbm).
Also referred to as Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Be capable of giving informed consent.
- Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV
- Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
- Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential
- Have a life expectancy \> 3 months
You likely can't join if
- Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any...
- Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
- Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
- Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
- Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the...
- Performance status, KPS \< 70
See the full eligibility criteria
- Be capable of giving informed consent.
- Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV
- Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
- Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential
- Have a life expectancy \> 3 months
- Be between the ages of 18 to 74
- Have a performance status KPS 70 or greater
- Be able to swallow pills and capsules
- Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings
- Have adequate bone marrow function, liver function and renal function before commencing therapy
- Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide...
- Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
- Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
- Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
- Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).
- Performance status, KPS \< 70
- Inability to swallow pills and capsules
- Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy
- Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine
- Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance
- Patients with renal insufficiency or hepatic insufficiency
- Patients with coagulopathies
- Women who are pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.