Kidney Cancer Clinical Trial
Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Houston Texas, 77055, United States
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