Stage IV Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer
Brief summary
Current therapies for Stage IV Kidney 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 Stage IV Kidney Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Kidney Cancer.
Detailed description
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV Kidney Cancer 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. OBJECTIVE S: * To determine the efficacy of Antineoplaston therapy in patients with Stage IV Kidney Cancer, 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 Kidney Cancer. * 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.
Interventions
DRUGAntineoplaston therapy (Atengenal + Astugenal)
Patients with Stage IV Kidney Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Sponsors
Burzynski Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV adenocarcinoma or transitional cell carcinoma of the kidney that is unlikely to respond to existing therapy * Measurable disease by MRI or CT scan * Tumor must be more than 2 cm for lymph nodes in head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm for other locations 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/mL * 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 severe lung disease, such as chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * Not a high medical or psychiatric risk * No concurrent nonmalignant systemic disease that would preclude therapy * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No concurrent immunomodulatory agents Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent antineoplastic agents Endocrine therapy: * 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
Countries
United States
Outcome results
None listed