Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003563
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Gadolinium Texaphyrin in Treating Patients With Brain Metastases
Sponsor:
Pharmacyclics LLC
Organization:
Pharmacyclics LLC
Study Overview
Official Title:
Phase III Randomized Trial of Gadolinium Texaphyrin PCI-0120 Injection as a Radiation Sensitizer in Patients Receiving Whole Brain Radiation Therapy for the Treatment of Brain Metastases
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Gadolinium texaphyrin may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation It is not yet known whether giving gadolinium texaphyrin with radiation therapy is more effective than radiation therapy alone in treating brain metastases
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without gadolinium texaphyrin in treating patients who have brain metastases
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without gadolinium texaphyrin in treating patients who have brain metastases
Detailed Description:
OBJECTIVES I Determine the safety of gadolinium texaphyrin administered prior to whole brain radiotherapy in patients with brain metastases II Compare the efficacy and toxicity of whole brain radiotherapy with or without gadolinium texaphyrin in these patients III Assess the quality of life of these patients
OUTLINE This is a randomized two stage multicenter study Patients are stratified according to RTOG recursive partitioning analysis class RPA class 1 vs class 2 and tumor type breast vs lung vs other Stage 1 lead-in All patients receive gadolinium texaphyrin IV over 5-10 minutes on the 10 days that they receive radiotherapy Approximately 2-5 hours later patients undergo whole brain radiotherapy Stage 2 randomization Patients are randomized to one of two treatment arms Patients in arm I undergo whole brain radiotherapy for 10 days Patients in arm II receive gadolinium texaphyrin and radiotherapy as in stage 1 Quality of life is assessed on days 10 and 28 then monthly for 5 months and then every 3 months thereafter Patients are followed at day 28 then monthly for 5 months and then every 3 months until death
PROJECTED ACCRUAL The lead-in phase will accrue at least 25-30 patients and the randomization phase will accrue 400 patients 200arm over a 12 month period
OUTLINE This is a randomized two stage multicenter study Patients are stratified according to RTOG recursive partitioning analysis class RPA class 1 vs class 2 and tumor type breast vs lung vs other Stage 1 lead-in All patients receive gadolinium texaphyrin IV over 5-10 minutes on the 10 days that they receive radiotherapy Approximately 2-5 hours later patients undergo whole brain radiotherapy Stage 2 randomization Patients are randomized to one of two treatment arms Patients in arm I undergo whole brain radiotherapy for 10 days Patients in arm II receive gadolinium texaphyrin and radiotherapy as in stage 1 Quality of life is assessed on days 10 and 28 then monthly for 5 months and then every 3 months thereafter Patients are followed at day 28 then monthly for 5 months and then every 3 months until death
PROJECTED ACCRUAL The lead-in phase will accrue at least 25-30 patients and the randomization phase will accrue 400 patients 200arm over a 12 month period
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-V98-1470 | None | None | None |
| PCI-P120-9801 | None | None | None |
| MSKCC-00088 | None | None | None |
| UCLA-9808021 | None | None | None |