Clinical trial · Interventional
Bevacizumab and Ascorbic Acid in Patients Treating With Recurrent High Grade Glioma
A Phase I Study of Bevacizumab and Intravenous Ascorbic Acid for Patients With Recurrent High Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial studies the side effects and best dose of ascorbic acid when given together with bevacizumab in treating patients with high grade glioma that has come back (recurrent). Monoclonal antibodies, such as bevacizumab may interfere with the ability of tumor cells to grow and spread. Ascorbic acid contains ingredients that may prevent or slow the growth of high grade glioma. Giving bevacizumab and ascorbic acid together may work better in treating patients with high grade glioma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic Acid | Dietary Supplement | — | UNRESOLVED |
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bevacizumab and ascorbic acid)
- description
- Patients receive ascorbic acid IV over 90-120 minutes three times per week (at least 24 hours apart) and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Dietary Supplement: Ascorbic Acid
- Biological: Bevacizumab
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
Primary outcomes (4)
- measure
- Frequency of occurrence of overall toxicity
- timeFrame
- Up to 52 weeks
- description
- Categorized by toxicity grades
- measure
- Incidence of dose limiting toxicities (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have pathologically proven diagnosis of high grade glioma * Patients must have received prior radiation therapy and standard temozolomide; patients who have received additional therapies for previous progressions will be considered eligible * Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression * Patients must have recovered from toxicity of prior therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or better * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Hemoglobin \>= 8 g/dL * Platelet count \>= 100,000/mm\^3 * Serum creatinine that is at or below 2.0 mg/dL * Serum aspartate transaminase (AST) and alanine transaminase (ALT) less than 1.5 times the upper limits of normal * Serum alkaline phosphatase less than 2.5 times the upper limits of normal * The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts * Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment * Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries) Exclusion Criteria: * History of uncontrollable allergic reactions to bevacizumab or ascorbic acid * Known human immunodeficiency virus (HIV)-positivity AND actively being treated with highly active antiretroviral therapy (HAART) * History of glucose-6-phosphate dehydrogenase deficiency * History of oxalate nephrolithiasis or urine oxalate \>60 mg/dL * Anuria, dehydration, severe pulmonary congestion or pulmonary edema or fixed low cardiac input * Prior hypersensitivity to bevacizumab or toxicity requiring discontinuation of bevacizumab * Clinically significant cardiovascular disease defined as follows: * Inadequately controlled hypertension (i.e., systolic blood pressure \[SBP\] \> 160 mm Hg and/or diastolic pressure \[DBP\] \> 90 mm Hg despite antihypertensive therapy) * History of cerebrovascular accident (CVA) within 6 months * Myocardial infarction or unstable angina within 6 months * Evidence or history of bleeding diathesis (greater than normal risk of bleeding, i.e., Hereditary Hemorrhagic Telangiectasia type I or HHT-1) or coagulopathy in the absence of therapeutic anti-coagulation or any hemorrhage/bleeding event \> grade 3 within 4 weeks prior to registration; note: patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose for at least 2 weeks of low molecular weight heparin; therapeutic Coumadin and aspirin doses \> 325 mg daily are not allowed * Active wound, a serious or non-healing wound, an active ulcer or untreated bone fracture * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =\< 6 months prior to registration * Major surgical procedure, open biopsy or significant traumatic injury =\< 28 days prior to registration * Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent * Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide; Note: high dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs * Simultaneous participation in other therapeutic clinical trials will not be allowed * Inability to co-operate with the requirements of the protocol * Pregnant and nursing women are excluded from this study
References
Publications (0)
Data not yet available