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

Phase 2TerminatedNCT00003497

Burzynski Research Institute9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stage IV Non-small Cell Lung Cancer

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Data from ClinicalTrials.gov

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