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Radiation + Temozolomide for Glioblastoma

Phase 1 & 2

Waitlist Available

Led By Shiao Woo, MD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have normal organ and marrow function: Leukocytes > 3,000/microliter, Absolute neutrophil count > 1,500/microliter, Platelets > 100,000/microliter, Total bilirubin within normal institutional limits, aspartate aminotransferase test(SGOT)/alanine aminotransferase test(SGPT) < 2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal, Ability to understand and the willingness to sign a written informed consent document

Participants must have histologically confirmed glioblastoma/gliosarcoma

Must not have

Participants may not have had chemotherapy wafer placement at surgery

Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, pi decision) or death from any cause, whichever is first, assessed up to 100 months.

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will study the effects of radiation and temozolomide on patients over 70 with cancer.

Who is the study for?

This trial is for patients over 70 with newly diagnosed glioblastoma who haven't had prior treatments. They must have a life expectancy of more than 6 months, good organ and marrow function, and be able to consent. Excluded are those with other cancers (unless low risk or certain types within the past 5 years), severe illnesses, or HIV on antiretrovirals.

What is being tested?

The study tests a combination of short-term radiation therapy (over two weeks) and Temozolomide chemotherapy during and after radiation in older adults. The goal is to see how well they tolerate this treatment regimen and its effectiveness against their brain cancer.

What are the potential side effects?

Temozolomide may cause nausea, vomiting, fatigue, constipation, loss of appetite or hair loss. Radiation could lead to headaches, scalp irritation or cognitive changes. Side effects vary by individual; some might experience few while others more.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is glioblastoma or gliosarcoma confirmed by tissue analysis.

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My tumor's MGMT promoter methylation status has been checked.

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I am over 70 years old.

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I am mostly independent and can care for myself.

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I have not received any treatment for glioblastoma multiforme.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had chemotherapy wafers placed during surgery.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am HIV-positive and not on antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, pi decision) or death from any cause, whichever is first, assessed up to 100 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, pi decision) or death from any cause, whichever is first, assessed up to 100 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, pi decision) or death from any cause, whichever is first, assessed up to 100 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients who stop treatment due to Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or above toxicities..

Overall survival

Secondary study objectives

Estimate progression-free survival (PFS)

Tolerability (feasibility) of hypo-fractionated radiaton therapy and Temozolomide

Other study objectives

Explore association of Overall Survival (OS) and Progression Free Survival (PFS) with 06-methylguanine-DNA methyltransferase gene (MGMT) methylation status

Explore changes in quality of life (QOL)

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314

36%

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

Aspartate aminotransferase increased

Mucositis oral

Anemia

Vomiting

Constipation

Dehydration

Hypophosphatemia

Platelet count decreased

Sepsis

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Catheter related infection

Colitis

Abdominal pain

Hypotension

White blood cell decreased

GGT increased

Hypocalcemia

Urinary retention

Hypoalbuminemia

Fever

Typhlitis

Anxiety

Neutrophil count decreased

Urinary tract infection

Peripheral motor neuropathy

Enterocolitis

Lipase increased

Pleural effusion

Serum amylase increased

Skin infection

Epistaxis

Urinary tract obstruction

Blood bilirubin increased

Lymphocyte count decreased

Syncope

Wound infection

Dermatitis radiation

Hypertension

Sinus tachycardia

Edema limbs

Bone pain

Dyspnea

Hematuria

Hypercalcemia

Vulval infection

Upper gastrointestinal hemorrhage

Thromboembolic event

Depressed level of consciousness

Stridor

Allergic reaction

Back pain

Lung infection

Urticaria

Acute kidney injury

Muscle weakness lower limb

Musculoskeletal and connective tissue disorder - Other, specify

Pain in extremity

Peripheral sensory neuropathy

Proctitis

Skin ulceration

Apnea

Stoma site infection

Tumor pain

Left ventricular systolic dysfunction

Pancreatitis

Portal hypertension

Rectal hemorrhage

Creatinine increased

Enterocolitis infectious

Hyperkalemia

Investigations - Other, specify

Abdominal distension

Ascites

Heart failure

Vascular disorders - Other, specify

Anal hemorrhage

Penile pain

Bone marrow hypocellular

Vasovagal reaction

Gastrointestinal disorders - Other, specify

Soft tissue infection

Delirium

Tracheitis

Seizure

Hepatobiliary disorders - Other, specify

Esophageal pain

Anal mucositis

Menorrhagia

Sore throat

Anaphylaxis

Fracture

Hydrocephalus

Device related infection

Tooth infection

Gastric ulcer

Sinusitis

Skin and subcutaneous tissue disorders - Other, specify

Pharyngitis

Pyramidal tract syndrome

Anal ulcer

Depression

Ejection fraction decreased

Rash maculo-papular

Pruritus

Myositis

Nail infection

Pain of skin

Pleuritic pain

Pneumonitis

Pneumothorax

Postoperative hemorrhage

Renal and urinary disorders - Other, specify

Respiratory, thoracic and mediastinal disorders - Other, specify

Salivary duct inflammation

Small intestine infection

Alkaline phosphatase increased

Appendicitis

Spinal fracture

Disseminated intravascular coagulation

Ear and labyrinth disorders - Other, specify

Endocrine disorders - Other, specify

Esophageal stenosis

Esophagitis

Gastric hemorrhage

Gum infection

Tumor lysis syndrome

Upper respiratory infection

Hypertriglyceridemia

Hypoxia

Ileus

INR increased

Laryngeal edema

Multi-organ failure

Myelodysplastic syndrome

Oral hemorrhage

Oral pain

Pulmonary edema

Rectal fistula

Rectal pain

Respiratory failure

Bladder spasm

Chest wall pain

Confusion

Congenital, familial and genetic disorders - Other, specify

CPK increased

Dizziness

Encephalopathy

Eye disorders - Other, specify

Generalized muscle weakness

Hoarseness

Hypernatremia

Hypoglycemia

Hypomagnesemia

Insomnia

Irregular menstruation

Irritability

Joint range of motion decreased cervical spine

Kyphosis

Lethargy

Headache

Laryngeal mucositis

Pelvic pain

Esophageal infection

Abdominal infection

Acidosis

Anal fistula

Fall

Fatigue

Gait disturbance

100%

80%

60%

40%

20%

Study treatment Arm

Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)

Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hypofractionated radiotherapy and temozolomideExperimental Treatment2 Interventions

All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

FDA approved

Hypofractionated radiotherapy

2015

Completed Phase 3

~510

0 / 9Eligibility criteria met