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



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

For Condition: stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: Recruiting
Sponsor(s): Burzynski Research Institute ,
Synopsis: RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial studies the effectiveness of antineoplaston capsules in treating patients who have stage IV non-small cell lung cancer.
Details: OBJECTIVES: - Demonstrate the antitumor activity of antineoplaston A10 and AS2-1 capsules in patients with non-small cell lung cancer by determining the proportion of patients who experience an objective tumor response. - Evaluate the adverse effects of and tolerance to this regimen in these patients. OUTLINE: This is an open-label study. Patients 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. Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StanislawBurzynski,  Study Chair,  Burzynski Research Institute

Burzynski Clinic *Recruiting*
Houston,  Texas,  77055-6330
United States
Recruiting Stanislaw  Burzynski 713-335-5697


Additional Information:
Study ID Numbers:  CDR0000066536;  BRI-LA-10
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003497

Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

2. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer

3. Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

4. A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer

5. Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

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