Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer

• Status: Terminated
• Trial end date: 1998-04-03
• Target enrollment: 0
• Participant gender: All

Summary

Current therapies for advanced Head and Neck Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Head and Neck Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Head and Neck Cancer.

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

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cancer of the head and neck that is unlikely to respond to existing therapy and for which no curative therapy exists

• Metastatic disease OR incurable with surgery or radiation

• Measurable disease by CT scan or MRI

• Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas

PATIENT CHARACTERISTICS:

Age:

• 16 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 2.5 mg/dL

Renal:

• No renal insufficiency

• Creatinine no greater than 2.5 mg/dL

• No renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No chronic heart failure

• 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 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 serious medical or psychiatric conditions

• 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

• No concurrent antineoplastic therapy

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics

• At least 8 weeks since prior radiotherapy (unless multiple tumors) and recovered

Surgery:

• See Disease Characteristics

Other:

• Prior cytodifferentiating agents allowed