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Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant 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 With Primary Malignant Brain Tumors


OBJECTIVES:

- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with
primary malignant 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 12 months in the absence of disease progression or unacceptable
toxicity. After 12 months, patients with responding or 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 incurable primary malignant brain tumor that has progressed,
recurred, or persisted after initial therapy

- Must have failed prior standard therapy

- No brain stem glioma

- Evidence of tumor by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

- 6 months to 17 years

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 1,500/mm^3

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

Hepatic:

- No hepatic failure

- Bilirubin no greater than 2.5 mg/dL

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

Renal:

- Creatinine no greater than 2.5 mg/dL

Cardiovascular:

- No severe heart disease

- 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 and recovered

- No concurrent immunomodulating agents

Chemotherapy:

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

- No concurrent antineoplastic agents

Endocrine therapy:

- Recovered from prior endocrine therapy

- Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (unless clear radiological evidence of
progression) and recovered

Surgery:

- At least 4 weeks since prior surgery (unless clear radiological evidence of
progression) and recovered

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 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:

CDR0000066513

NCT ID:

NCT00003476

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood low-grade cerebral astrocytoma
  • childhood craniopharyngioma
  • childhood central nervous system germ cell tumor
  • childhood high-grade cerebral astrocytoma
  • childhood oligodendroglioma
  • childhood choroid plexus tumor
  • childhood grade I meningioma
  • childhood grade II meningioma
  • childhood grade III meningioma
  • 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