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Alkylating agent
Temozolomide for Glioblastoma
Phase 1
Waitlist Available
Led By Vinay Puduvalli
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have completed standard radiation therapy with concurrent TMZ and must not have evidence of progressive disease on post-treatment imaging
Patients with histologically proven supratentorial glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV astrocytoma) or low-grade glioma with subsequent histological diagnosis of glioblastoma or gliosarcoma prior to definitive treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial studies the side effects of giving a combination of drugs to people with glioblastoma multiforme.
Who is the study for?
This trial is for adults with glioblastoma or gliosarcoma who've finished radiation therapy. They must have a decent performance status, stable blood counts, normal liver and kidney function, and no progressive disease post-treatment. Women should not be pregnant and all participants must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests the safety and optimal doses of temozolomide combined with memantine hydrochloride, mefloquine, and metformin hydrochloride in treating brain tumors after radiation. It aims to see if this drug combo can make cancer cells more sensitive to treatment.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, fatigue, blood cell count changes leading to increased infection risk or bleeding problems; liver or kidney function alterations; neurological issues like confusion or seizures from memantine; heart rhythm changes due to mefloquine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I finished standard radiation and TMZ therapy without my cancer getting worse.
Select...
I have been diagnosed with a specific type of brain tumor called glioblastoma or gliosarcoma.
Select...
I am mostly able to care for myself but may need occasional help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Median overall survival (OS)
Median progression free survival (PFS)
PFS
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%
Anemia
9%
Mucositis oral
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%
Anxiety
5%
Typhlitis
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%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
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%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
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)
Trial Design
8Treatment groups
Experimental Treatment
Group I: Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine)Experimental Treatment4 Interventions
Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, metformin hydrochloride PO BID as in Arm 4, and mefloquine PO QD as in Arm 3.
Group II: Arm 7 (temozolomide, mefloquine, metformin hydrochloride)Experimental Treatment3 Interventions
Patients receive temozolomide PO as in Arm 1, mefloquine PO QD as in Arm 3, and metformin hydrochloride PO BID as in Arm 4.
Group III: Arm 6 (temozolomide, memantine hydrochloride, metformin)Experimental Treatment3 Interventions
Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and metformin hydrochloride PO BID as in Arm 4.
Group IV: Arm 5 (temozolomide, memantine hydrochloride, mefloquine)Experimental Treatment3 Interventions
Patients receive temozolomide PO and memantine hydrochloride PO BID as in Arm 2, and mefloquine PO QD as in Arm 3.
Group V: Arm 4 (temozolomide, metformin hydrochloride)Experimental Treatment2 Interventions
Patients receive temozolomide PO as in Arm 1 and metformin hydrochloride PO BID.
Group VI: Arm 3 (temozolomide, mefloquine)Experimental Treatment2 Interventions
Patients receive temozolomide PO as in Arm 1 and 30 mg mefloquine PO QD on days 1-3 of week 1 and then days 2, 4, and 6 every other week.
Group VII: Arm 2 (temozolomide, memantine hydrochloride)Experimental Treatment2 Interventions
Patients receive temozolomide PO as in Arm 1 and memantine hydrochloride PO BID.
Group VIII: Arm 1 (temozolomide)Experimental Treatment1 Intervention
Patients receive temozolomide PO QD on days 1-5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved
Mefloquine
FDA approved
Temozolomide
FDA approved
Memantine
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,658 Total Patients Enrolled
42 Trials studying Glioblastoma
1,825 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,933,075 Total Patients Enrolled
322 Trials studying Glioblastoma
22,971 Patients Enrolled for Glioblastoma
Vinay PuduvalliPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
35 Total Patients Enrolled
1 Trials studying Glioblastoma
35 Patients Enrolled for Glioblastoma
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Arm 4 (temozolomide, metformin hydrochloride)
- Group 2: Arm 8 (TMZ, memantine hydrochloride, metformin, mefloquine)
- Group 3: Arm 7 (temozolomide, mefloquine, metformin hydrochloride)
- Group 4: Arm 3 (temozolomide, mefloquine)
- Group 5: Arm 6 (temozolomide, memantine hydrochloride, metformin)
- Group 6: Arm 1 (temozolomide)
- Group 7: Arm 2 (temozolomide, memantine hydrochloride)
- Group 8: Arm 5 (temozolomide, memantine hydrochloride, mefloquine)
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 20 Other Conditions - This treatment demonstrated efficacy for 20 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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