Antineoplaston Therapy in Treating Patients With Primary Malignant 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, adult medulloblastoma, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult central nervous system germ cell tumor, adult subependymoma, adult ependymoblastoma, adult pineoblastoma, adult meningeal hemangiopericytoma, adult choroid plexus tumor, adult grade III meningioma, adult grade II meningioma, adult giant cell glioblastoma, adult gliosarcoma, adult supratentorial primitive neuroectodermal tumor (PNET), 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 primary malignant brain tumors.
Detailed Description
OBJECTIVES:

- Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable primary malignant brain tumor that has progressed during or is recurrent or persistent after prior standard therapy, including radiotherapy and/or chemotherapy.

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

OUTLINE: Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Patients are followed at least 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: Approximately 20-40 patients will be accrued for this study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed incurable primary malignant brain tumor that has progressed during or is recurrent after prior initial therapy, including radiotherapy

- Failed prior standard therapy

- Measurable disease by MRI or CT scan

- No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- Hematological function normal

- WBC at least 2000/mm^3

- Platelet count at least 50,000/mm^3

Hepatic:

- No liver failure

- No evidence of hepatic insufficiency

- Bilirubin no greater than 2.5 mg/dL

- SGOT/SGPT no greater than 5 times upper limit of normal

Renal:

- No evidence of renal insufficiency

- Creatinine no greater than 2.5 mg/dL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- No uncontrolled hypertension

- No history of congestive heart failure

- No chronic heart failure

- No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

- No serious lung disease, such as 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 medical or psychiatric illness that would preclude study treatment

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy

- No concurrent immunomodulating agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy

- At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy

- No concurrent antineoplastic agents

Endocrine therapy:

- Corticosteroids allowed

Radiotherapy:

- See Disease Characteristics

- At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy

Surgery:

- At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy

Other:

- Recovered from prior therapy

- Cytodifferentiating agents allowed
Location
Burzynski Clinic
Houston, Texas, United States
Status: Recruiting
Contact: Stanislaw R. Burzynski, MD, PhD - 713-335-5697 - info@burzynskiclinic.com
Start Date
February 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