Antineoplaston Therapy in Treating Patients With Brain Tumors
Conditions
Brain and Central Nervous System Tumors
Conditions: official terms
Brain Neoplasms - Central Nervous System Neoplasms - Nervous System Neoplasms
Conditions: Keywords
recurrent adult brain tumor, ACTH-producing pituitary tumor, TSH producing pituitary tumor, adult brain stem glioma, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult glioblastoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult central nervous system germ cell tumor, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, adult pineocytoma, adult pineoblastoma, adult meningeal hemangiopericytoma, adult choroid plexus tumor, adult grade III meningioma, adult giant cell glioblastoma, adult gliosarcoma, adult pineal gland astrocytoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: antineoplaston A10 Type: Drug
Name: antineoplaston AS2-1 Type: Drug
Overall Status
Recruiting
Summary
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with brain tumors.
Detailed Description
OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening brain tumors.

- Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: 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 2 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. Patients achieving partial response or stable disease continue treatment until disease progression.

Tumors are measured every 1-3 months for 2 years, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter.

PROJECTED ACCRUAL: Not specified
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histologically confirmed (except brain stem locations) brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists

- Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron emission tomography

- Tumor must be at least 5 mm

- Ineligible for other BRI brain tumor protocols

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- Hemoglobin at least 9 g/dL

- 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

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

- No concurrent immunomodulating agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- 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

Surgery:

- Must recover from prior surgery

Other:

- Prior cytodifferentiating agent allowed

- No prior antineoplaston therapy
Location
Burzynski Clinic
Houston, Texas, United States
Status: Recruiting
Contact: Stanislaw R. Burzynski, MD, PhD - 713-335-5697 - info@burzynskiclinic.com
Start Date
July 1996
Sponsors
Burzynski Research Institute
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page