Capecitabine and Temozolomide for Newly Diagnosed GBM
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
Recruiting
Phase 1Phase 2Interventional Study
Glioblastoma Multiforme (GBM)GlioblastomaGlioma of BrainGlioblastoma, AdultBrain TumorBrain Tumor, PrimaryBrain Tumor AdultCancerBrain Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 74
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
67 (estimated)
Sponsor
Northwell Health · Other
Who this trial is looking for
This trial is looking for adults who have been diagnosed with glioblastoma multiforme and have completed their initial treatment. Participants will take the medication capecitabine along with temozolomide to see if it improves treatment response.
Are You a Good Fit for This Trial?
You may be able to join if
I have a confirmed diagnosis of glioblastoma multiforme.
I have completed 6 weeks of standard chemo-radiation.
I agree to use effective contraception if I can become pregnant.
I am 18 to 74 years old.
I have a performance status score of 70 or higher.
I can swallow pills and capsules.
I have adequate bone marrow, liver, and kidney function.
I expect to live more than 3 months.
You may not be able to join if
I have had chemotherapy with capecitabine or temozolomide before.
I have a history of severe allergic reaction to capecitabine or temozolomide.
I cannot swallow pills and capsules.
I have a serious illness that would prevent me from participating.
I have had another cancer in the last 5 years except for certain types.
My performance status score is below 70.
I am currently undergoing other chemotherapy for my disease.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 o…
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.
Trial Locations
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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 temozolomid…
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.
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