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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer  Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
For Condition: recurrent non-small cell lung cancer,adenocarcinoma of the lung,stage 4 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 therapy in treating patients who have stage IV lung cancer.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable adenocarcinoma of the lung. - Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Tumors are measured every 2 months for 1 year and then every 3 months for 1 year. 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 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
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: CDR0000066530; BC-LA-3
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003491
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
2. Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
3. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
4. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
5. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
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