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 range
14 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.