Clinical trial · Interventional
Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA
- 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)
In order to test the investigators hypothesis that 8 teaspoons of POLYMVA is safe in a population of patients with grade IV brain astrocytoma (glioblastoma multiforme), the investigators will conduct an open-label, prospective, un-blinded study. The investigators expect that at least 70% of subjects will tolerate the supplement and complete the trial. The investigators expect no Serious Adverse Event to occur during this trial which is attributable to study compound. During this study, the investigators will also collect other qualitative data to be utilized for future double-blinded studies which will be aimed at determining whether grade IV astrocytoma patients who receive PolyMVA achieve a better quality of life during their chemo-therapeutic regimens versus grade IV astrocytoma patients who do not receive PolyMVA.
Conditions
Conditions (1)
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 Multiform (Grade IV Astrocytoma) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PolyMVA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PolyMVA
- description
- This arm will be taking 8 tsp/day of the study compound (PolyMVA) in addition to receiving normal care as determined by his/her neuro-oncologist.
- interventionNames
- Drug: PolyMVA
Primary outcomes (1)
- measure
- The Number and Severity of Adverse events as a Measure of Safety and Tolerability
- timeFrame
- 34 Weeks
- description
- Adverse Events will be recorded throughout the course of the study and scaled for severity according to CTCAE v. 4.02. AE's will also be scaled for relatedness to the study compound and will be adjudicated by a DSMB. MRIs will be obtained at baseline, 26 weeks ans 34 weeks. We will look for disease progression according to MacDonald criteria. Blood work and urinalysis will also be obtained at every visit. Tolerability will be based upon subject questioning.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 -79 years. Women of procreative potential who agree to practice abstinence or use adequate contraceptive methods during the study (i.e., two methods of contraception) may enroll. Female subjects of childbearing potential should have a negative serum pregnancy test within three days prior to treatment, and a repeat pregnancy test should be performed when the patient exits the study. * Non-smoker (must be smoke-free at least 2 years). * Able to sign informed consent. * Naïve to Poly MVA * Biopsy-proven grade IV brain astrocytoma * Must be MRI-compatible. * Lesion must be supra-tentorial Exclusion Criteria: * History of neuro-psychiatric disease other than the astrocytoma, including Stroke, Cerebral Hemorrhage, Multiple Sclerosis, Dementia, Severe Depression/Suicidal Ideation, Parkinson's disease, carotid occlusion or high-grade stenosis (\>69%), occlusion of major vessel in circle of Willis, CADASIL, Schizophrenia. * History of allergy to food supplementation/vitamin/mineral (including nickel). * Known severe hepatic or renal failure (i.e., baseline liver function panel greater than 3 times the upper limit of normal and serum creatinine greater than 2 times the upper limit of normal). * Congestive Heart Failure. * Other terminal illness with life expectancy \<3 years due to that disease (e.g. end-stage AIDS). * Current substance abuse. * Unable to sign informed consent. * Current participation in another clinical study. * Chronic steroid use, other than steroids prescribed for brain swelling * Any other condition, which, in the opinion of the investigator, places the subject into the category of poor physical health. * Subjects with other pre-existing cancer. * Subjects with newly diagnosed astrocytoma who have not yet undergone primary surgical resection and/or who have not yet completed their primary course of radiation therapy are not eligible. If during the course of the study the subject's oncologist decides to initiate a second course of radiation therapy, then PolyMVA must be discontinued. * Lesions with PNET cells will be excluded. * Karnofsky Performance Status less than 70. * Subjects who are pregnant or currently breastfeeding may not enroll in the study.
References
Publications (0)
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