Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM (CAPTEM)
Primary Purpose
Glioblastoma Multiforme (GBM), Glioblastoma, Glioma of Brain
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme (GBM)
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Lenox Hill Brain Tumor CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine amd Temozolomide
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
Overall Survival (OS)
OS will be calculated as the time from treatment initiation to the date of death.
Secondary Outcome Measures
Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)
Subjects will be classified according to the RECIST criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03.
Proportions of subjects experiencing these toxicities will be estimated using standard methods for proportions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03213002
Brief Title
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
Acronym
CAPTEM
Official Title
Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
There were an estimated 22,000 new cases of brain cancers in 2015 in the United States, and 15,000 deaths (Howlader et al., 2014). Glioblastoma (WHO IV), and Anaplastic Astrocytoma (WHO III), are the most common brain cancers, respectively, representing over 70% of all malignant gliomas (ABTA, 2015).
Though rare, there is no cure, and the prognosis for these tumors is poor. Survival at 5 years for all CNS cancers is approximately 33.3 % (Howlader et al., 2014). For GBM, the most lethal of the tumors, with the current standard of care median survival is 14.6 months (Walid, 2008). Relative survival with GBM at five years is approximately only 5% (Ostrom et al. CBTRUS 2014).
For newly diagnosed tumors, the current standard of care recommends a multi-modal approach with surgery to remove the tumor, when possible, followed by 6 weeks of radiation and a concurrent daily dose of temozolomide (Stupp et al. 2005). This is known as the Stupp protocol (Stupp et al. 2005). Patients then have a one-month rest period with no treatment, followed by "maintenance" temozolomide, given five days out of every 28 days, for a minimum of six months. Some providers keep patients on temozolomide beyond 6 months, or until disease progression.
Therefore, more therapies are needed to help improve survival, reduce time to recurrence and improve quality of life for these patients. This trial proposes to improve the current standard of care by enhancing the efficacy of an active drug temozolomide, currently used for treatment of GBM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme (GBM), Glioblastoma, Glioma of Brain, Glioblastoma, Adult, Brain Tumor, Brain Tumor, Primary, Brain Tumor Adult, Cancer, Brain Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine amd Temozolomide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine at 1500 mg/m2
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
Temozolomide at 150 mg/m2 - 200 mg/m2
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
Time Frame
6 months
Title
Overall Survival (OS)
Description
OS will be calculated as the time from treatment initiation to the date of death.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)
Description
Subjects will be classified according to the RECIST criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
Time Frame
6 months
Title
Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03.
Description
Proportions of subjects experiencing these toxicities will be estimated using standard methods for proportions.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Boockvar, MD
Phone
212-434-3900
Email
jboockvar@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tamika Wong, MPH
Phone
212-434-4836
Email
twong4@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Boockvar, MD
Organizational Affiliation
Lenox Hill Hospital-Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lenox Hill Brain Tumor Center
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamika Wong, MPH
Phone
212-434-4836
Email
twong4@northwell.edu
First Name & Middle Initial & Last Name & Degree
John Boockvar, MD
First Name & Middle Initial & Last Name & Degree
David Langer, MD
First Name & Middle Initial & Last Name & Degree
Anuj Goenka, MD
First Name & Middle Initial & Last Name & Degree
Christopher Filippi, MD
First Name & Middle Initial & Last Name & Degree
Lalitha Anand, MD
First Name & Middle Initial & Last Name & Degree
Sherese Fralin, NP
First Name & Middle Initial & Last Name & Degree
Ashley Ray, NP
First Name & Middle Initial & Last Name & Degree
Tamika Wong, MPH
12. IPD Sharing Statement
Learn more about this trial
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
We'll reach out to this number within 24 hrs