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Phase II Study of Antineoplastons A10 and AS2-1 in Children Wtih Brain Tumors


Phase 2
N/A
17 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Study of Antineoplastons A10 and AS2-1 in Children Wtih Brain Tumors


OBJECTIVES:

- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with
brain tumors by determining the proportion of patients who experience an objective
tumor response.

- Evaluate the adverse effects of and tolerance to this regimen in these children.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment
continues for at least 2 months in the absence of disease progression or unacceptable
toxicity. Patients achieving stable disease may continue treatment.

Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth
years, every 6 months for the fifth and sixth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed (except if medically contraindicated) severe pediatric brain
tumor that is unlikely to respond to existing therapy and for which no curative
therapy exists

- Histology requirement may be waived for brain stem tumors

- Measurable tumor by MRI or CT scan

- Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

- 6 months to 17 years

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC greater than 2000/mm^3

- Platelet count greater than 50,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

- SGOT and SGPT no greater than 5 times upper limit of normal

- No hepatic failure

Renal:

- Creatinine no greater than 2.5 mg/dL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No severe heart disease

- No history of heart failure

- No history of other cardiovascular conditions that contraindicate high dosages of
sodium

- No uncontrolled hypertension

Pulmonary:

- No severe lung disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No serious active infections or fever

- No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy

- No concurrent immunomodulating agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No concurrent antineoplastic agents

Endocrine therapy:

- Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at
least 1 week before study entry)

Radiation therapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from any prior surgery

Other:

- No prior antineoplaston therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate based on tumor measurements taken at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

Unspecified

Study ID:

CDR0000066490

NCT ID:

NCT00003458

Start Date:

September 1996

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood craniopharyngioma
  • childhood central nervous system germ cell tumor
  • childhood oligodendroglioma
  • childhood choroid plexus tumor
  • recurrent childhood brain stem glioma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • recurrent childhood medulloblastoma
  • recurrent childhood visual pathway and hypothalamic glioma
  • recurrent childhood ependymoma
  • recurrent childhood pineoblastoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330