Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA

NCT01833273 | Completed Phase 1 DMC

• 1 other identifier: DESSTINI_A
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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

Glioblastoma Multiform (Grade IV Astrocytoma)

Outcome Measures

Primary Outcomes (1)

• The Number and Severity of Adverse events as a Measure of Safety and Tolerability

  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.

  34 Weeks

Study Arms (1)

PolyMVA

EXPERIMENTAL

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.

Drug: PolyMVA

Interventions

PolyMVA DRUG

Subjects will take 8 tsp/day of PolyMVA over a 26 week period while receiving standard of care from his/her neuro-oncologist. Subjects will begin taking the study compound after maximal surgical resection of the tumor and receiving an initial treatment of radiation therapy. Subjects will not take study compound on days when they receive chemotherapy.

PolyMVA

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead
• Garnett McKeen Laboratory Inc.: collaborator

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Candice Perkins, MD

  Stony Brook University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: April 16, 2013
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2015
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

US (1)