Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Anaplastic Astrocytoma
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Anaplastic Astrocytoma
OBJECTIVES:
- Determine the objective response rate in patients with anaplastic astrocytoma treated
with antineoplastons A10 and AS2-1 after subtotal resection.
- Assess 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
IV 6 times daily until the maximum tolerated dose is reached. Treatment continues for at
least 2 months in the absence of unacceptable toxicity or disease progression. Patients
achieving stable disease or partial response may continue treatment. Patients achieving
complete response (CR) continue treatment for an additional 8 months after CR.
Tumors are measured at 1 month, every 1-2 months for 2 years, every 3 months for the third
year, every 4 months for the fourth year, every 6 months for the fifth year, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed anaplastic astrocytoma
- Tumor subtotally resected or biopsied
- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT
scan, or positron-emission tomography
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- No hepatic failure
Renal:
- Creatinine no greater than 2.5 mg/dL
- No renal failure
Cardiovascular:
- No prior congestive heart failure
- No coronary artery disease
- No myocardial infarction within the past year
- No angina requiring medication
- No uncontrolled hypertension
Pulmonary:
- No moderate to severe chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
participation
- No active infection
- No other concurrent serious disease
- No other prior malignancy except carcinoma in situ of the cervix or superficial
nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- No prior myelosuppressive chemotherapy
Endocrine therapy:
- Concurrent corticosteroids for cerebral edema allowed
Radiotherapy:
- No prior myelosuppressive radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any prior surgery
Other:
- No prior cytodifferentiating agents
- No prior antineoplaston therapy
- No other concurrent antineoplastic agents
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:
Unspecified
Study ID:
CDR0000066585
NCT ID:
NCT00003537
Start Date:
April 1995
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult anaplastic astrocytoma
- Astrocytoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Burzynski Clinic | Houston, Texas 77055-6330 |
