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Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma


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 High Grade Glioma


OBJECTIVES:

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

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

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment
continues for at least 12 months in the absence of unacceptable toxicity or disease
progression. 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 high-grade glioma, glioblastoma multiforme, or
anaplastic astrocytoma that is refractory or recurrent, or with residual tumor after
standard therapy, including radiotherapy

- Evidence of tumor by gadolinium-enhanced MRI or contrast-enhanced CT scan

- No brain stem tumor

PATIENT CHARACTERISTICS:

Age:

- 6 months to 17 years

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC greater than 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

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

- No hepatic failure

Renal:

- Creatinine no greater than 2.5 mg/dL

- No renal insufficiency

Cardiovascular:

- No severe heart disease

- No uncontrolled hypertension

- No history of congestive heart failure

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 therapy

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- See Disease Characteristics

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

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:

United States: Federal Government

Study ID:

CDR0000066582

NCT ID:

NCT00003535

Start Date:

August 1993

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood high-grade cerebral astrocytoma
  • recurrent childhood cerebral astrocytoma
  • childhood cerebral astrocytoma/malignant glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330