Phase I Study of Interstitial Colloidal 32P Integrated With External Radiation Therapy and Chemotherapy in the Treatment of Non-Resectable or Medically Inoperable Non-Small Cell Carcinoma of the Lung
OBJECTIVES: I. Determine the dosimetry and toxicity of interstitial phosphorus P32 colloid
plus chemotherapy and radiotherapy in patients with previously untreated stage II, IIIA, or
IIIB non-small cell lung cancer. II. Determine the maximum tolerated dose of phosphorus P32
colloid in these patients. III. Determine the response in patients treated with this
OUTLINE: This is a dose escalation study of phosphorus P32 colloid. Patients receive
vinblastine IV on days 1, 8, 15, 22, and 29; cisplatin IV over 30-60 minutes on days 1 and
29; and phosphorus P32 colloid interstitially on day 50. Patients with tumor size less than
8.0 cm receive radiotherapy following phosphorus P32 injection 5 days a week for 6.5 weeks.
Patients with tumor size greater than 8.0 cm receive radiotherapy 5 days a week for 4.5
weeks prior to phosphorus P32 injection, and for an additional 2.5 weeks following
injection. Cohorts of 3 patients receive escalating doses of phosphorus P32 colloid until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 patients experience dose limiting toxicity. Patients are followed every
3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 4 years.
Primary Purpose: Treatment
Wayne S. Court, MD, PhD
Center for Molecular Medicine
United States: Federal Government
|Center for Molecular Medicine||Garden City, New York 11530|