Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

Stage IV Cancer of the Cervix and/or Vulva patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: - To determine the efficacy of Antineoplaston therapy in patients with Stage IV Cancer of the Cervix and/or Vulva, as measured by an objective response to therapy (complete response, partial response or stable disease). - To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Cancer of the Cervix and/or Vulva. - To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.


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


NCT ID:

NCT00003525


Primary Contact:

Principal Investigator
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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