Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2003-06-21
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.

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

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy)

• Measurable disease by MRI or CT scan

• Brain stem tumor is excluded

• Tumor must be at least 5 mm

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm3

• Platelet count at least 50,000/mm3

Hepatic:

• No liver failure

• Bilirubin no greater than 2.5 mg/dL

• SGOT/SGPT no greater than 5 times upper limit

Renal:

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

• Creatinine no greater than 2.5 mg/dL

Cardiovascular:

• No uncontrolled hypertension

• No history of congestive heart failure

• No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease (e.g., severe COPD)

Other:

• Not pregnant or nursing

• Fertile patients must use adequate contraception during and for 4 weeks after study

• No active infection

• No other serious medical or psychiatric conditions

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since immunotherapy

• No concurrent immunomodulating agents

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since chemotherapy (unless radiologically proven progression)

• At least 6 weeks since nitrosoureas

Endocrine therapy:

• Corticosteroids allowed

Radiotherapy:

• See Disease Characteristics

• At least 8 weeks since radiotherapy (unless radiologically proven progression)

Surgery:

• Recovered from prior surgery

Other:

• No prior antineoplaston therapy

• Prior cytodifferentiating agent allowed