Lung Cancer Clinical Trial
Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
Summary
Current therapies for Stage IV non-small cell 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
Stage IV non-small cell lung cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
To determine the efficacy of Antineoplaston therapy in patients with Stage IV non-small cell 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 non-small cell lung cancer.
To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV non-small cell lung cancer that cannot be cured with existing therapeutic regimens
Measurable disease by CT scan or MRI
Tumor must be at least 2 cm for the lymph nodes located in the head, neck, axillary, inguinal or femoral areas and at least 0.5 cm for other areas
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
Cardiovascular:
No chronic heart failure
No uncontrolled hypertension
Pulmonary:
No serious lung disease (e.g., severe chronic obstructive pulmonary disease)
Other:
Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
No other serious medical or psychiatric conditions
No active infection
No serious malabsorption syndromes
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
Concurrent corticosteroids allowed
Radiotherapy:
At least 8 weeks since prior radiotherapy (less than 8 weeks if multiple tumors are involved) and recovered
Surgery:
No prior extensive stomach or intestinal surgery
Recovered from any prior surgery
Other:
Prior cytodifferentiating agents allowed
No prior antineoplaston treatment
No other concurrent treatment for metastatic lung cancer
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There is 1 Location for this study
Houston Texas, 77055, United States
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