Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors
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 Primitive Neuroectodermal Tumors
OBJECTIVES:
- Demonstrate the antitumor activity of antineoplastons A10 and AS2-1 in children with
primitive neuroectodermal 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 patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times a day until the maximum tolerated dose is reached. Treatment
continues for at least 2 months in the absence of disease progression or unacceptable
toxicity. After 2 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 (except if medically contraindicated) incurable primitive
neuroectodermal tumor
- Evidence of progressive or recurrent tumor by MRI or CT scan performed within 2
weeks prior to study entry
- Must have received and failed prior standard therapy
- Tumor must be at least 5 mm
PATIENT CHARACTERISTICS:
Age:
- 6 months to 17 years
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2000/mm^3
- Platelet count greater than 50,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- No hepatic insufficiency
Renal:
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No uncontrolled hypertension
- No severe heart disease
- 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 a stable dose for
at least 1 week prior to study entry)
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- No prior antineoplaston treatment
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate assessed by 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:
CDR0000066492
NCT ID:
NCT00003460
Start Date:
September 1995
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent childhood supratentorial primitive neuroectodermal tumor
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
Name | Location |
|---|---|
| Burzynski Clinic | Houston, Texas 77055-6330 |
