Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva

• Status: Terminated
• Trial end date: 1998-01-22
• Target enrollment: 0
• Participant gender: Female

Summary

Current therapies for Stage IV Cancer of the Cervix and/or Vulva provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Cancer of the Cervix and/or Vulva.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Cancer of the Cervix and/or Vulva.

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

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven incurable stage IV carcinoma of the uterine cervix and/or vulva that is unlikely to respond to existing therapy

• Measurable disease by MRI or CT scan

• Tumor must be at least 2 cm

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm^3

• Platelet count at least 50,000/mm^3

Hepatic:

• No hepatic insufficiency

• Bilirubin no greater than 2.5 mg/dL

• SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

• No renal insufficiency

• Creatinine no greater than 2.5 mg/dL

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

Cardiovascular:

• No known chronic heart failure

• No uncontrolled hypertension

• No history of congestive heart failure

• No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease, such as chronic obstructive pulmonary disease

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Not a high medical or psychiatric risk

• No concurrent nonmalignant systemic disease

• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunomodulatory agents

Chemotherapy:

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

Endocrine therapy:

• At least 1 month since prior tamoxifen if no progression

• May enter study immediately if evidence of progression

• Concurrent corticosteroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed

• No prior antineoplastons

• No other concurrent antineoplastic agents