NCT03213002 Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
| NCT ID | NCT03213002 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Northwell Health |
| Condition | Glioblastoma Multiforme (GBM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 67 participants |
| Start Date | 2017-06-13 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 67 participants in total. It began in 2017-06-13 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: 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.
Contact & Investigator
John Boockvar, MD
PRINCIPAL INVESTIGATOR
Lenox Hill Hospital-Northwell Health
Frequently Asked Questions
Who can join the NCT03213002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Glioblastoma Multiforme (GBM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03213002 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03213002 currently recruiting?
Yes, NCT03213002 is actively recruiting participants. Contact the research team at jboockvar@northwell.edu for enrollment information.
Where is the NCT03213002 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03213002 clinical trial?
NCT03213002 is sponsored by Northwell Health. The principal investigator is John Boockvar, MD at Lenox Hill Hospital-Northwell Health. The trial plans to enroll 67 participants.
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