Status:
COMPLETED
Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
Garnett McKeen Laboratory Inc.
Conditions:
Glioblastoma Multiform (Grade IV Astrocytoma)
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is a Phase I Safety Study which investigates the role of PolyMVA as a supplement in grade IV astrocytoma patients. The primary endpoint of this study is safety/tolerability. This supplement, Pol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01833273
Start Date
July 1 2010
End Date
June 1 2015
Last Update
June 3 2016
Active Locations (1)
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1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794