Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Antineoplastons A10 and AS2-1 Capsules In Patients With Non Small Cell Lung Cancer

Conditions
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Stage IV Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Antineoplaston therapy (Atengenal + Astugenal)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antineoplastons<br>Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity. | Drug: Antineoplaston therapy (Atengenal + Astugenal)<br>* Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.<br>* Other names: A10 (Atengenal); AS2-1 (Astugenal);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer