What side effects are associated with this type of intervention?

The most common treatments for Glioblastoma, such as Temozolomide, can cause side effects including nausea, vomiting, fatigue, constipation, headache, and myelosuppression (neutropenia and thrombocytopenia). The investigational drug OKN-007, which is being studied for its potential anti-angiogenic, anti-inflammatory, or cytotoxic effects, may have side effects that are not yet fully characterized but could include inflammation or vascular-related issues.

What prior FDA approvals exist?

Temozolomide, an oral alkylating agent, was approved by the FDA for the treatment of newly diagnosed glioblastoma in combination with radiotherapy and as maintenance therapy. It works by methylating DNA, which leads to tumor cell death. Bevacizumab, an anti-angiogenic drug that inhibits vascular endothelial growth factor (VEGF), was also approved for recurrent glioblastoma. These treatments align with the mechanisms of action being studied in the trial involving OKN-007 and Temozolomide.

What other types of research exist?

Promising novel alternatives for Glioblastoma treatment in 2024 include: <ol> <li>GD2-CAR T cell therapy: This therapy targets H3K27M-mutated diffuse midline gliomas and has shown potential in preclinical studies.</li> <li>ONC201: A selective DRD2 antagonist that has demonstrated efficacy in recurrent glioblastoma.</li> <li>Bevacizumab: An anti-VEGF antibody that inhibits angiogenesis and has been used in combination with other therapies.</li> <li>Ivosidenib and Vorasidenib: Inhibitors of mutant IDH1 and IDH2, respectively, showing promise in recurrent/progressive glioma.</li> <li>Checkpoint inhibitors (e.g., Pembrolizumab, Nivolumab): These immunotherapies have shown potential in treating glioblastoma by enhancing the immune response against tumor cells.</li> </ol>

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OKN-007 + Temozolomide for Glioblastoma

Q: What is the mechanism of action of this treatment?

Temozolomide, a common treatment for Glioblastoma, works by alkylating/methylating DNA, leading to tumor cell death by disrupting DNA replication and repair. OKN-007, currently under investigation, is believed to exert anti-angiogenic, anti-inflammatory, or cytotoxic effects, which can inhibit tumor growth and reduce inflammation. These mechanisms are important for Glioblastoma patients as they provide targeted approaches to disrupt tumor growth and improve treatment outcomes.

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

Must not have

Second primary malignancy (except adequately treated basal cell carcinoma of the skin)

Have received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding the drug OKN-007 to the standard treatment with Temozolomide and radiotherapy can help patients with malignant Glioblastoma, especially those whose cancer has gotten worse after initial treatment. Temozolomide has become a cornerstone in the treatment of glioblastoma, often used in combination with radiotherapy.

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.

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.

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.

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I have fully recovered from any side effects of previous treatments or surgeries.

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My blood tests show normal kidney, liver, and bone marrow function.

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I can provide at least five tissue samples from my brain tumor surgery for testing.

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I am 18 years old or older.

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I have been recently diagnosed with a high-grade brain tumor.

Exclusion Criteria

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

Select...

I have no other cancers except for treated skin cancer.

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I haven't taken any unapproved drugs in the last 28 days.

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My blood tests show high levels of sodium, potassium, or creatinine.

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I am not pregnant or breastfeeding.

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My kidneys are not working well (creatinine clearance < 60 mL/min).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

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

Primary study objectives

The maximum tolerated dose and the type of dose limiting toxicities

Secondary study objectives

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

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

Heart failure

Ascites

Vascular disorders - Other, specify

Anal hemorrhage

Penile pain

Vasovagal reaction

Gastrointestinal disorders - Other, specify

Soft tissue infection

Delirium

Tracheitis

Hepatobiliary disorders - Other, specify

Seizure

Esophageal pain

Anal mucositis

Menorrhagia

Sore throat

Bone marrow hypocellular

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

No Placebo-Only Group

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

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

~1880

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Temozolomide, a common treatment for Glioblastoma, works by alkylating/methylating DNA, leading to tumor cell death by disrupting DNA replication and repair. OKN-007, currently under investigation, is believed to exert anti-angiogenic, anti-inflammatory, or cytotoxic effects, which can inhibit tumor growth and reduce inflammation. These mechanisms are important for Glioblastoma patients as they provide targeted approaches to disrupt tumor growth and improve treatment outcomes.