Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006212
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2000-09-11
Brief Title:
Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
Sponsor:
Center for Molecular Medicine
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status Verified Date:
2001-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 80 cm receive radiotherapy following phosphorus P32 injection 5 days a week for 65 weeks Patients with tumor size greater than 80 cm receive radiotherapy 5 days a week for 45 weeks prior to phosphorus P32 injection and for an additional 25 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
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 80 cm receive radiotherapy following phosphorus P32 injection 5 days a week for 65 weeks Patients with tumor size greater than 80 cm receive radiotherapy 5 days a week for 45 weeks prior to phosphorus P32 injection and for an additional 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1586 | None | None | None |
| CMM-99003 | None | None | None |