NCT00006212

Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Center for Molecular Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as phosphorus-32 may make the tumor cells more sensitive to radiation therapy. Chemotherapy combined with radiation therapy and phosphorus-32 may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of phosphorus-32 plus radiation therapy and chemotherapy in treating patients who have stage II or stage III non-small cell lung cancer.

Detailed description

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 regimen. 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	vinblastine sulfate
RADIATION	phosphorus P32
RADIATION	radiation therapy

Timeline

• Start date: 1999-11-01
• First posted: 2004-05-26
• Last updated: 2013-09-17

Locations

1 site across 1 country: United States