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Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Stem Glioma


Phase 2
N/A
N/A
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 Patients With Brain Stem Glioma


OBJECTIVES:

- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with
brain stem 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 disease progression or unacceptable
toxicity. After 12 months, patients with a complete or partial response 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 (except if medically contraindicated) brain stem 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

PATIENT CHARACTERISTICS:

Age:

- 6 months and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2,000/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 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
participation

- No serious active infections or fever

- No other serious concomitant 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:

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

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 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:

CDR0000066491

NCT ID:

NCT00003459

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult brain stem glioma
  • untreated childhood brain stem glioma
  • recurrent childhood brain stem glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330