Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||3 Years - 99 Years|
- - Subjects with Diffuse, Intrinsic Pontine Glioma as defined by the following criteria are eligible: - A characteristic MRI appearance, including variable contrast enhancement after gadolinium administration, diffuse T2/FLAIR signal, and involvement of more than 50% of the pons.
- - Confirmation of anaplastic glioma (i.e., oligodendroglioma, astrocytoma, oligoastrocytoma) or GBM histology if there is less than 50% involvement of the pons.
- - Screening evaluation requires a MRI performed within 14 days prior to the start of ANP therapy.
- - Subjects 3-21 years of age must have a clinical history of disease of less than 6 months and at least two of the following clinical findings: cranial nerve deficit, long tract signs (i.e. hemiparesis) and ataxia are eligible.
- - Subjects must be ≥ 3 years of age.
- - Subjects ≤ 16 years of age with a Lansky performance status of > 40 are eligible.
- - Subjects with organ and marrow function (as defined below) are eligible.
- - Hemoglobin ≥ 9 g/dL.
- - Leukocytes > 2000/mm3.
- - Absolute neutrophil count >1,000/ mm3.
- - Serum Na+ ≤ 150 mmol/L.
- - Serum K+ ≤ 5.5 mmol/L.
- - Serum creatinine ≤ 1.5 times institutional upper limit.
- - Platelets >50,000/ mm3.
- - Total bilirubin < 2.5 mg/dL.
- - AST (SGOT) / ALT (SGPT) <5 times institutional upper limit.
- - At the recommended therapeutic dose, the effects of ANP therapy on the developing human fetus are unknown.
- - Subjects, parents, and/or guardians who are able to understand a written informed consent document, and are willing to sign it, are eligible.
- - No type of prior therapy, including other investigational agents, is allowable.
- - Subjects with disseminated disease, multicentric tumors, leptomeningeal disease, or the history of retrotumoral bleeding are not eligible.
- - Subjects with a known history of ganglioglioma are not eligible.
- - Subjects with a current diagnosis or family history of neurofibromatosis I or II are not eligible.
- - Subjects with a current diagnosis or family history of neurofibromatosis are not eligible.
- - Subjects with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension despite maximal medical management (three supine blood pressure measurements ≥ 150/99 taken at least one hour apart) or psychiatric illness/social situations that would limit compliance with protocol study requirements are not eligible.
- - Subjects with a history of New York Heart Association Class II congestive heart failure are not eligible.
- - Pregnant women are not eligible because the teratogenic and abortifacient effects of ANP therapy in humans are unknown.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Burzynski Research Institute|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Stanislaw R. Burzynski, MD, PhD|
|Principal Investigator Affiliation||Burzynski Research Institute|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Brain Stem Glioma|
|Study Website:||View Trial Website|
This is a randomized Phase 3 protocol study of Antineoplaston therapy + radiation therapy vs.#46; radiation therapy alone in subjects ≥ 3 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma. In those subjects randomized to Antineoplaston therapy + radiation therapy, Antineoplaston therapy is administered for 104 weeks while radiation therapy commences on day one of Antineoplaston therapy and continues for 6 weeks. Subjects continue on Antineoplaston therapy if an objective response or stable disease is achieved during therapy and are maintained on Antineoplaston therapy to the end of the protocol study unless they develop progressive disease. Subjects randomized to radiation therapy alone receive 6 weeks of radiation therapy. Exploratory objectives are to compare the following in the two treatment arms: 1) overall survival for study subjects ≥ 21 years of age; 2) progression-free survival for subjects ≥ 21 years of age; 3) objective response, complete response, partial response, and progressive disease rates, based on the enhancing portion of the tumor, for all subjects, using bidimentional measurement of tumor; 4) objective response, complete response, partial response, and progressive disease rates, for all subjects with non-enhancing tumors, using unidimentional measurement of tumor; and 5) objective response, complete response, partial response, and progressive disease rates, based on the enhancing + non-enhancing portions of the tumor, for all subjects, using unidimentional measurement of tumor.
Study subjects receive a single daily radiation fraction of 180cGy, 5 days a week for 6 weeks overall, to a total radiation dose of 5400cGy.
Experimental: Antineoplaston therapy + Radiation
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for 104 weeks. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Study subjects also receive a single daily radiation fraction of 180cGy, 5 days a week for 6 weeks overall, to a total radiation dose of 5400cGy.
Radiation: - Radiation
Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive radiation.
Drug: - Atengenal
Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
Drug: - Astugenal
Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Stanislaw R Burzynski, M.D., Ph.D.
For additional contact information, you can also visit the trial on clinicaltrials.gov.