Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with recurrent or refractory oligodendroglioma.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4
months for the third and fourth years, every 4-6 months for the fifth year, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed incurable oligodendroglioma that progressed
during or is recurrent or residual after initial therapy, including radiotherapy
and/or chemotherapy
- Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron-emission
tomography
- Measurable disease by MRI or CT scan
- Tumor must be at least 5 mm
- Must have received and failed prior standard therapy (i.e., radiotherapy,
chemotherapy, immunotherapy, or cytodifferentiating agent)
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 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 history of other cardiovascular conditions that contraindicate high dosages of
sodium
Pulmonary:
- No severe lung disease (e.g., chronic obstructive pulmonary disease)
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
participation
- No serious active infections
- No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy
Surgery:
- Recovered from any prior surgery
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:
United States: Federal Government
Study ID:
CDR0000066509
NCT ID:
NCT00003472
Start Date:
May 1996
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult anaplastic oligodendroglioma
- adult oligodendroglioma
- Nervous System Neoplasms
- Oligodendroglioma
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Burzynski Clinic | Houston, Texas 77055-6330 |
