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OKN-007 + Temozolomide for Glioblastoma

Phase 1
Waitlist Available
Led By James Battiste, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status within 0 - 2
Full recovery (< grade 1) from the adverse events associated with prior surgery or any earlier intervention and a minimum of 28 days from the administration of any investigational agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new drug combination to see if it can help people with cancer who have gotten worse after other treatments.

Who is the study for?
Adults with newly diagnosed Glioblastoma who've had surgery can join this trial. They need to provide tumor tissue, have a performance status of 0-2, and good organ function. Men must use contraception and not donate sperm for 120 days post-treatment. Women of childbearing potential must test negative for pregnancy and use birth control.Check my eligibility
What is being tested?
The study tests OKN-007 combined with Temozolomide chemotherapy alongside standard radiotherapy in patients with Glioblastoma to see if it improves outcomes after initial treatment failure.See study design
What are the potential side effects?
Potential side effects may include those typical of chemoradiotherapy such as fatigue, nausea, hair loss, skin irritation from radiation, low blood cell counts increasing infection risk, liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have fully recovered from any side effects of previous treatments or surgeries.
Select...
My blood tests show normal kidney, liver, and bone marrow function.
Select...
I can provide at least five tissue samples from my brain tumor surgery for testing.
Select...
I am 18 years old or older.
Select...
I have been recently diagnosed with a high-grade brain tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The maximum tolerated dose and the type of dose limiting toxicities
Secondary outcome measures
Number of participants who are able to receive a reduction in steroid dose
Number of participants who comply with study treatment plan
Number of participants who experience overall survival
+1 more

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
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%
Syncope
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
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

2Treatment groups
Experimental Treatment
Group I: OKN-007 5 days per week and temozolomideExperimental Treatment3 Interventions
OKN-007: 60 mg/kg, IV, 5 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions
Group II: OKN-007 3 days per week plus temozolomideExperimental Treatment3 Interventions
OKN-007: 60 mg/kg, IV, 3 times a week Temozolomide: 75 mg/m2, oral, once daily for 42 days Radiotherapy: 60 Gy administered in 30 fractions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,805 Total Patients Enrolled
3 Trials studying Glioblastoma
65 Patients Enrolled for Glioblastoma
James Battiste, MDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Glioblastoma
15 Patients Enrolled for Glioblastoma

Media Library

Photon/Proton IMRT Clinical Trial Eligibility Overview. Trial Name: NCT03587038 — Phase 1
Glioblastoma Research Study Groups: OKN-007 3 days per week plus temozolomide, OKN-007 5 days per week and temozolomide
Glioblastoma Clinical Trial 2023: Photon/Proton IMRT Highlights & Side Effects. Trial Name: NCT03587038 — Phase 1
Photon/Proton IMRT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03587038 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions is Temozolomide typically employed for?

"Temozolomide is an effective therapy for those who have been prescribed nitrosourea treatment, drafted advanced directives and are dealing with refractory forms of mycosis fungoides."

Answered by AI

Who is the ideal candidate to partake in this experiment?

"This clinical trial requires participants to have glioblastoma and fall within the age range of 18-99 years old. The total number of enrollees is expected to be 6 individuals."

Answered by AI

To what extent is Temozolomide potentially hazardous to individuals?

"Temozolomide is in the early stages of clinical testing, thus it has been assigned a rating of 1 for safety. This reflects its limited data demonstrating efficacy and safety."

Answered by AI

Have there been any antecedent investigations involving the use of Temozolomide?

"Temozolomide is currently the subject of 206 clinical trials, 23 of which are at Phase 3. While most locations conducting these studies are based in Seoul Songpa, there are 4752 sites that have registered to participate."

Answered by AI

What is the scope of participants involved in this clinical research?

"Affirmative, clinicaltrials.gov data shows that this medical trial is actively searching for applicants. Launched on September 3rd 2018 and last updated June 17th 2022, the study seeks 6 patients from a single site."

Answered by AI

Are enrollment numbers still open for this research project?

"The data hosted on clinicaltrials.gov affirms that recruitment for this trial is still taking place. The entry was initialised on September 3rd, 2018 and the most recent amendment occurred on June 17th, 2022."

Answered by AI

Does this investigation represent an unprecedented exploration of its kind?

"Through 36 countries and 935 cities, 206 live Temozolomide trials are occurring. The initial experiment for this drug began in 2002, sponsored by Schering-Plough with a total of 60 participants who managed to complete the Phase 2 approval stage. Since then, an additional 296 clinical studies have been conducted."

Answered by AI

Does the eligibility criteria for this medical study include persons aged 55 and older?

"Subject to the terms and conditions of this research, individuals that are between 18 - 99 years old may join."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
2018. "OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03587038.
All > Recurrent Glioblastoma > Glioblastoma Multiforme
~4 spots leftby May 2025
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