Antineoplaston Therapy in Treating Patients With Primary Liver Cancer (NCT00003530) | Clinical Trial Compass
TerminatedPhase 2
Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
Stopped: Slow accrual
United States3 participantsStarted 1977-03-21
Plain-language summary
Current therapies for Primary Liver 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 Primary Liver 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.
Who can participate
Age range14 Years – 99 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed primary liver cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
* Measurable disease by CT scan or MRI
* Tumor must be at least 2 cm
PATIENT CHARACTERISTICS:
Age:
* 14 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:
* Bilirubin less than 3 mg/dL
* SGOT/SGPT no greater than 10 times upper limit of normal
* No hepatic failure
Renal:
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high doses of sodium
Cardiovascular:
* No uncontrolled hypertension
* No known chronic heart failure
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high doses of sodium
Pulmonary:
* No serious lung disease (e.g., chronic obstructive pulmonary disease)
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception for 4 weeks before study, during study, and for 4 weeks after study
* No serious medical or psychiatric disease
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No concurrent antineoplastic agents
Endocrine ther…