Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma
N/A
17 Years
Both
Brain and Central Nervous System Tumors
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 Clinic | Houston, Texas 77055-6330 |
