RECRUITING

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Conditions

Glioblastoma Multiforme (GBM)Glioblastoma Glioma of Brain Glioblastoma, Adult Brain Tumor Brain Tumor, Primary Brain Tumor Adult Cancer Brain Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.

Official Title

Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)

Quick Facts

Study Start:2017-06-13

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03213002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be capable of giving informed consent. 2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV 3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide 4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential 5. Have a life expectancy \> 3 months 6. Be between the ages of 18 to 74 7. Have a performance status KPS 70 or greater 8. Be able to swallow pills and capsules 9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings 10. Have adequate bone marrow function, liver function and renal function before commencing therapy	1. 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, respectively, will be excluded. 2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation. 3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions), 4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection) 5. 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). 6. Performance status, KPS \< 70 7. Inability to swallow pills and capsules 8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy 9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine 10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance 11. Patients with renal insufficiency or hepatic insufficiency 12. Patients with coagulopathies 13. Women who are pregnant or lactating.

Inclusion Criteria

Exclusion Criteria

1. Be capable of giving informed consent.
2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV
3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential
5. Have a life expectancy \> 3 months
6. Be between the ages of 18 to 74
7. Have a performance status KPS 70 or greater
8. Be able to swallow pills and capsules
9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings
10. Have adequate bone marrow function, liver function and renal function before commencing therapy

1. 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, respectively, will be excluded.
2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
5. 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).
6. Performance status, KPS \< 70
7. Inability to swallow pills and capsules
8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy
9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine
10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance
11. Patients with renal insufficiency or hepatic insufficiency
12. Patients with coagulopathies
13. Women who are pregnant or lactating.

Contacts and Locations

Study Contact

John Boockvar, MD

CONTACT

212-434-3900

jboockvar@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836

twong4@northwell.edu

Principal Investigator

John Boockvar, MD

PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital-Northwell Health

Study Locations (Sites)

Lenox Hill Brain Tumor Center

New York, New York, 10075

United States

Collaborators and Investigators

Sponsor: Northwell Health

John Boockvar, MD, PRINCIPAL_INVESTIGATOR, Lenox Hill Hospital-Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-06-13

Study Completion Date2026-06

Study Record Updates

Study Start Date2017-06-13

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma Multiforme (GBM)
Glioblastoma
Glioma of Brain
Glioblastoma, Adult
Brain Tumor
Brain Tumor, Primary
Brain Tumor Adult
Cancer
Brain Cancer