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Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway 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 Infusions in Children With Visual Pathway Glioma


OBJECTIVES:

- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with
visual pathway 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 antineoplastons A10 and AS2-1 6
times per day until the maximum tolerated dose is reached. Treatment continues for at least
12 months in the absence of disease progression and unacceptable toxicity. After 12 months,
patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks during the first 2 years, every 3 months during the third
and fourth years, every 6 months during the fifth and sixth years, and yearly thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed (unless medically contraindicated) visual pathway glioma
that is unlikely to respond to existing therapy and for which no curative therapy
exists

- Evidence of tumor by MRI or CT scan

- Tumor must be at least 5 mm

- No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

- 6 months to 17 years

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2000/mm3

- Platelet count greater than 50,000/mm3

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

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

Cardiovascular:

- No severe heart disease

- No uncontrolled hypertension

- No history of congestive heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No severe lung disease

Other:

- Not pregnant or nursing

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

- 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 and recovered (6 weeks for nitrosoureas)

- No concurrent antineoplastic agents

Endocrine therapy:

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

Radiotherapy:

- 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 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:

CDR0000066514

NCT ID:

NCT00003477

Start Date:

June 1996

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood visual pathway glioma
  • recurrent childhood visual pathway glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330