Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer

Launched by BURZYNSKI RESEARCH INSTITUTE · Jan 26, 2003

Keywords

ClinConnect Summary

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV or Recurrent Lung Cancer 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 or Recurrent Lung Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed recurrent or stage IV squamous cell 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/mm3
• • Platelet count at least 50,000/mm3
• 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
• • No serious active infections
• • No other serious concurrent disease
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • At least 4 weeks since prior immunotherapy and recovered
• • No concurrent immunomodulating agents
• Chemotherapy:
• • At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered
• • No concurrent antineoplastic agents
• 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