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 April 1996
End date January 2008
Trial size 40 participants
Trial identifier NCT00003492, BC-LA-4, CDR0000066531

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 is studying how well antineoplaston therapy works in treating patients with stage IV lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response rate based on tumor measurements taken at 12 weeks
time frame:

Secondary Outcomes

Measure
Survival at 1, 2, and 5 years from the start of treatment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed large cell, undifferentiated, or poorly differentiated stage IV lung cancer unlikely to have a curative response to existing standard regimens - Measurable disease by MRI or CT scan - At least 2 cm in diameter 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: - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal - No hepatic failure 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 severe heart disease - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No serious active infections - No other concurrent serious disease PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulating agent Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agent Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - No prior antineoplaston therapy - Prior cytodifferentiating agent allowed

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Large Cell, Undifferentiated Or Poorly Differentiated Stage IV Carcinoma of the Lung
Description OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with large cell, undifferentiated, or poorly differentiated stage IV lung cancer. - 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 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for 1 year and then every 3 months for the second year. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).