Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma

• Status: Terminated
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Current therapies for adult recurrent/progressive low grade astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adult recurrent/progressive low grade astrocytoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with a recurrent/progressive low grade astrocytoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed low-grade astrocytoma that has progressed, recurred, or persisted after initial therapy, including radiotherapy

• Previously treated with at least 1 prior standard therapy (e.g., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent)

• Measurable tumor by MRI scan performed within two weeks prior to study entry

• Tumor must be at least 5 mm

• 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 2,000/mm^3

• Platelet count at least 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 failure

Renal:

• Creatinine no greater than 2.5 mg/dL

• No renal insufficiency

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

Cardiovascular:

• No uncontrolled hypertension

• No chronic heart failure

• 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 other concurrent serious disease

• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunomodulating agents

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Must recover from prior surgery

Other:

• No prior antineoplastons