Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.

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

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma

• Tumor subtotally resected or biopsied prior to therapy

• Evidence of residual tumor by MRI scan performed within two weeks prior to study entry

• 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 1,500/mm^3

• Platelet count at least 50,000/mm^3

• Hemoglobin at least 10 g/dL

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 failure

Cardiovascular:

• No prior congestive heart failure

• No coronary artery disease

• No myocardial infarction within the past year

• No angina requiring medication

• No uncontrolled hypertension

Pulmonary:

• No moderate to 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 active infection

• No other concurrent serious disease

• No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy

• No concurrent immunomodulating agents

Chemotherapy:

• No prior myelosuppressive chemotherapy

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

• No prior myelosuppressive radiotherapy

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

• Recovered from any prior surgery

Other:

• No prior cytodifferentiating agents

• No prior antineoplaston therapy

• No other concurrent antineoplastic agents