Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003798
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Cancer of the Pancreas That Cannot Be Removed by Surgery
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase I Study Involving Gadolinium Texaphyrin NSC 695238 in Patients With Pancreatic and Periampullary Adenocarcinoma Receiving Radiotherapy for Unresectable Disease
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy
PURPOSE Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have cancer of the pancreas that cannot be removed by surgery
PURPOSE Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have cancer of the pancreas that cannot be removed by surgery
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of gadolinium texaphyrin in patients with locally advanced unresectable pancreatic or periampullary adenocarcinoma undergoing local regional radiotherapy II Determine the toxic effects of gadolinium texaphyrin with concurrent radiotherapy in these patients III Correlate estimates of tumor and normal organ gadolinium texaphyrin uptake and retention over time by MRI with plasmaserum levels in these patients
OUTLINE This is a dose escalation study Patients receive gadolinium texaphyrin IV over 5-10 minutes 4 times weekly at least 2 hours prior to external beam radiotherapy over 25 weeks total of 10 fractions Cohorts of 3-6 patients are treated at escalating doses of gadolinium texaphyrin The maximum tolerated dose is defined as the highest dose level in which dose limiting toxicity occurs in no more than 2 of 6 patients Patients are followed once monthly for 2 months
PROJECTED ACCRUAL A total of 45 evaluable patients will be accrued for this study within 18-24 months
OUTLINE This is a dose escalation study Patients receive gadolinium texaphyrin IV over 5-10 minutes 4 times weekly at least 2 hours prior to external beam radiotherapy over 25 weeks total of 10 fractions Cohorts of 3-6 patients are treated at escalating doses of gadolinium texaphyrin The maximum tolerated dose is defined as the highest dose level in which dose limiting toxicity occurs in no more than 2 of 6 patients Patients are followed once monthly for 2 months
PROJECTED ACCRUAL A total of 45 evaluable patients will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-98062407 | None | None | None |
| NCI-T97-0115 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |