Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Feb 5, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Burzynski Research Institute
- Interventions being studied
- Drug: Antineoplaston therapy (Atengenal + Astugenal)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Burzynski ClinicHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 5, 2018. Always confirm current availability with the study team.