Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Current therapies for adults with primary malignant brain tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with primary malignant brain tumors that have not responded to standard therapy.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with primary malignant brain tumors that have not responded to standard therapy.

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

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed incurable adult primary malignant brain tumor

• Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry

• Must have received and failed standard therapy

• Tumor must be at least 5 mm

• 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