Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA
Condition: Glioblastoma Multiform (Grade IV Astrocytoma)
MeSH terms: Glioblastoma; Astrocytoma
Study type: Interventional
Phase: Phase 1

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.
    

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, PolyMVA, is a uniquely formulated combination of minerals, vitamins, and
      amino acids. The principle ingredient is the Palladium Lipoic Acid Complex (PdLA). There is
      no free alpha-lipoic acid or free palladium in Poly MVA; they are bound together (Garnett
      1995, Krishnan and Garnett 2005). PolyMVA is both water and lipid soluble. It is uniquely
      arranged in a liquid crystal polymer structure, allowing it to store a great deal of energy,
      and thus serve as a semi-conductor. The overall function of this polymer is that it provides
      a unified redox reaction (accepts and donates charge), and acts as a highly effective
      energy-transferring molecule. It is able to rapidly and efficiently transfer electron charge
      to DNA, protecting non-cancerous cells from the oxidative damage of radiation and
      chemotherapy.

      Over the past years neuroscientists from our institution have used tissue culture techniques
      to study the effects of PolyMVA (PdLA) on the apoptotic cell death cascade in cancer cells.
      The work was predicated on the Nobel Prize winning discovery by Dr. Otto Warburg that
      cancerous tumors are oxygen deficient and rely upon anaerobic metabolism for energy
      production. Malignant cells have thus adapted to function in a hypoxic environment; however,
      since anaerobic metabolism produces less energy per unit of fuel, tumor cells are less
      efficient at energy production than normal healthy cells. PolyMVA (PdLA) takes advantage of
      this metabolic situation. PolyMVA (PdLA), by transferring excess electrons to malignant cells
      (which are functioning in a limited oxygen environment), is responsible for the selective
      generation of free radicals within the mitochondrial membrane of malignant cells. Free
      radical generation in this region facilitates cytochrome c release, activation of the
      apoptotic cascade, and, ultimately, cancer cell death.

      Furthermore, electrochemistry data and ischemia data from our institution both have
      elucidated that shuttled electrons do not go directly to DNA, but pass via the mitochondria.
      (This route was determined by competitively blocking the efficiency of PolyMVA (PdLA) with
      free alpha lipoic acid, which works at complex I of the mitochondria.) Therefore, electrons,
      en route to DNA, are shunted down the electron transport chain. The result: enhanced cellular
      energy in a non-malignant cell. (Clinically, this is a process which would not only benefit
      cancer patients who, as a result of toxic therapeutic regimens and cancerous invasion, are
      energy-depleted; but this would also benefit normal healthy subjects who experience fatigue,
      or, who are simply looking for an energy boost.)

      Poly MVA not only functions as an energy-transferring molecule, but also as a free radical
      scavenger (it is able to quench radical species). It is the combination of these activities,
      which may benefit cells exposed to ischemic conditions. During an ischemic insult, Poly MVA
      has the ability to shuttle electrons from the plasma cell membrane to the mitochondria, and
      thus stabilize the vulnerable electron transfer chain. Additionally, its liquid crystal
      polymer activity has the ability to quench any radicals generated upon reperfusion. This
      non-toxic novel supplement may therefore serve as a potent anti-ischemia agent.

      Hypothesis:

      Eight teaspoon daily dosage of PolyMVA in grade IV astrocytoma patients is safe and
      well-tolerated.
    

Intervention name(s): PolyMVA
Intervention type(s): Drug
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment