Cervical Cancer Stage IV Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Uterine Cervix and/or Vulva
Verified date | September 2017 |
Source | Burzynski Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | January 22, 1998 |
Est. primary completion date | January 22, 1998 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Burzynski Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Burzynski Research Institute |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03339765 -
Self-Advocacy Serious Game in Advanced Cancer
|
N/A |