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Anti-metabolites
CAPTEM for Glioblastoma (CAPTEM Trial)
Phase 1 & 2
Recruiting
Led By John Boockvar, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a pathology proven diagnosis of newly diagnosed Glioblastoma Multiforme WHO IV
Be able to tolerate oral chemotherapeutic medications with no health-threatening allergies or side effects based on lab and clinical findings
Must not have
Performance status KPS < 70
Prior chemotherapy with capecitabine or temozolomide for other prior malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
This trial will help researchers learn whether adding capecitabine to the standard oral temozolomide treatment for newly diagnosed GBM is safe and improves patient outcomes.
Who is the study for?
This trial is for adults aged 18-74 with newly diagnosed Glioblastoma Multiforme who've finished initial chemo-radiation but not started maintenance temozolomide. Participants must be able to take oral medication, have a life expectancy over 3 months, use effective contraception if applicable, and have good organ function. Exclusions include prior treatment with similar drugs, serious illnesses or conditions that interfere with consent or treatment, recent other cancers (except certain treated cases), pregnancy/lactation, and severe drug allergies.
What is being tested?
The study tests the safety and effectiveness of capecitabine combined with temozolomide in treating new glioblastoma multiforme after radiation therapy. It aims to see if adding capecitabine improves patient response compared to standard care which is just temozolomide alone.
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues such as nausea, vomiting, diarrhea, fatigue, hand-foot syndrome (redness/pain/swelling of palms/soles), low blood cell counts leading to increased infection risk or bleeding problems. Heart complications could occur especially in those with pre-existing heart disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of brain tumor called Glioblastoma.
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I can take oral chemotherapy without severe allergies or side effects.
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I am mostly independent and can care for myself.
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I am between 18 and 74 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need assistance with my daily activities.
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I have had chemotherapy with capecitabine or temozolomide for another cancer.
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I am not currently undergoing any chemotherapy or using devices like Optune for my condition.
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I have only used temozolomide during radiation for my brain cancer.
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I cannot swallow pills or capsules.
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I am not taking Coumadin or phenytoin medications.
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I am not pregnant or breastfeeding.
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I do not have any serious health or mental conditions that prevent me from understanding the treatment.
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I have kidney or liver problems.
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I have a blood clotting disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS)
Progression-free survival (PFS)
Secondary study objectives
Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)
Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03.
Side effects data
From 2016 Phase 2 trial • 175 Patients • NCT0105531436%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Aspartate aminotransferase increased
9%
Mucositis oral
9%
Anemia
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Typhlitis
5%
Anxiety
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Blood bilirubin increased
3%
Lymphocyte count decreased
3%
Syncope
3%
Wound infection
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Vulval infection
2%
Upper gastrointestinal hemorrhage
2%
Depressed level of consciousness
2%
Thromboembolic event
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Heart failure
1%
Vascular disorders - Other, specify
1%
Anal hemorrhage
1%
Ascites
1%
Vasovagal reaction
1%
Penile pain
1%
Bone marrow hypocellular
1%
Gastrointestinal disorders - Other, specify
1%
Soft tissue infection
1%
Delirium
1%
Tracheitis
1%
Seizure
1%
Hepatobiliary disorders - Other, specify
1%
Esophageal pain
1%
Anal mucositis
1%
Menorrhagia
1%
Sore throat
1%
Anaphylaxis
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Capecitabine amd TemozolomideExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved
Temozolomide
FDA approved
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
473 Previous Clinical Trials
469,575 Total Patients Enrolled
16 Trials studying Glioblastoma
806 Patients Enrolled for Glioblastoma
John Boockvar, MD3.916 ReviewsPrincipal Investigator - Lenox Hill Hospital-Northwell Health
Northwell Health
13 Previous Clinical Trials
758 Total Patients Enrolled
11 Trials studying Glioblastoma
717 Patients Enrolled for Glioblastoma
5Patient Review
This neurosurgeon is a true hero and miracle worker.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need assistance with my daily activities.I have heart disease and need a heart doctor's approval before starting capecitabine.I have had chemotherapy with capecitabine or temozolomide for another cancer.I am not currently undergoing any chemotherapy or using devices like Optune for my condition.I have only used temozolomide during radiation for my brain cancer.I have been cancer-free for a year, except for treated early-stage cancers in the last 5 years.I cannot swallow pills or capsules.I am not taking Coumadin or phenytoin medications.I am not pregnant or breastfeeding.I understand the study and can agree to participate.I have been diagnosed with a type of brain tumor called Glioblastoma.My bone marrow, liver, and kidneys are working well.I've finished the initial 6-week chemo-radiation but haven't started maintenance therapy.I can swallow pills and capsules.I do not have any serious health or mental conditions that prevent me from understanding the treatment.I have kidney or liver problems.I can take oral chemotherapy without severe allergies or side effects.I am mostly independent and can care for myself.I have a blood clotting disorder.I am between 18 and 74 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Capecitabine amd Temozolomide
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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