Stage IV Lung Cancer
Conditions
Keywords
non-small cell adenocarcinoma of the lung
Brief summary
Current therapies for Stage IV 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
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV lung cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Stage IV 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 lung cancer. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
Interventions
DRUGAntineoplaston therapy (Atengenal + Astugenal)
Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Sponsors
Burzynski Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed