Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date August 1998
Trial size 40 participants
Trial identifier NCT00003491, BC-LA-3, CDR0000066530

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Lung
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).