Lung Cancer Clinical Trial
Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Summary
Current therapies for Stage IV lung 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 lung cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV lung cancer.
Full Description
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV lung cancer 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 lung 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 lung 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 of the lung that is unlikely to respond to existing therapy and for which no curative therapy exists
Measurable disease by MRI or CT scan
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/SGPT no greater than 5 times upper limit of normal
Renal:
Creatinine no greater than 2.5 mg/dL
No renal insufficiency
No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
No chronic heart disease that would preclude study treatment
No history of chronic heart failure
No uncontrolled hypertension
No history of congestive heart failure
No history of cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
No lung disease that would preclude study treatment
No serious lung disease (e.g., severe chronic obstructive pulmonary disease)
Neurologic:
No neurological disease that would preclude study treatment
Other:
Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
No gastrointestinal or psychiatric disease that would preclude study treatment
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
No concurrent antineoplastic agents
Endocrine therapy:
Concurrent corticosteroids allowed
Radiotherapy:
At least 8 weeks since prior radiotherapy and recovered
Surgery:
Not specified
Other:
Prior cytodifferentiating agents allowed
No prior antineoplaston therapy
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There is 1 Location for this study
Houston Texas, 77055, United States
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