Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT03213002
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Capecitabine at 1500 mg/m2
  • Temozolomide — DRUG
    Temozolomide at 150 mg/m2 - 200 mg/m2

Study Details

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.

Key Dates

Start date
Jun 13, 2017
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Capecitabine amd Temozolomide
    Oral Capecitabine at 1500 mg/m2 divided into twice daily dosing, taken on days 1-14, and Temozolomide at 150 mg/m2 - 200 mg/m2 divided into twice daily dosing, taken on days 10-14; days 15-28 off.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lenox Hill Brain Tumor CenterNew YorkNew York10075
Tamika Wong, MPH
[email protected]
212-434-4836
John Boockvar, MD (PRINCIPAL_INVESTIGATOR)
David Langer, MD (SUB_INVESTIGATOR)
Anuj Goenka, MD (SUB_INVESTIGATOR)
Christopher Filippi, MD (SUB_INVESTIGATOR)
Lalitha Anand, MD (SUB_INVESTIGATOR)
Sherese Fralin, NP (SUB_INVESTIGATOR)
Ashley Ray, NP (SUB_INVESTIGATOR)
Tamika Wong, MPH (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Lenox Hill Brain Tumor Center· New York, NY

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