Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Collaborator: Garnett McKeen Laboratory Inc.

Criteria

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.