Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003751
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
1999-11-01
Brief Title:
Penicillamine Low Copper Diet and Radiation Therapy in Treating Patients With Glioblastoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Study of Penicillamine and Reduction of Copper for Angiosuppressive Therapy of Adults With Newly Diagnosed Glioblastoma
Status:
COMPLETED
Status Verified Date:
2012-05
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 Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor A diet low in copper may interfere with the growth of brain tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells Combining these therapies may be effective in treating glioblastoma
PURPOSE Phase II trial to study the effectiveness of penicillamine a low copper diet and radiation therapy in treating patients who have newly diagnosed glioblastoma
PURPOSE Phase II trial to study the effectiveness of penicillamine a low copper diet and radiation therapy in treating patients who have newly diagnosed glioblastoma
Detailed Description:
OBJECTIVES I Determine the effect of penicillamine and copper reduction on survival and time to progression in adults with newly diagnosed glioblastoma II Determine the effect of penicillamine on the reduction of serum copper in these patients III Determine whether penicillamine reduces the tumor volume vascularity invasion and edema in these patients
OUTLINE Patients receive oral penicillamine on the following schedule Week 1 once daily Week 2 two times daily Week 3 three times daily Week 4 four times daily Week 5 to end of study increased dose four times daily Patients also receive oral pyridoxine daily and maintain a low copper diet no greater than 05 mgday This regimen is continued for up to 2 years in the absence of disease progression or unacceptable toxicity Radiotherapy is administered over 6 weeks beginning on day 1 of penicillamine therapy Patients are followed every month with MRI every 2 months until death
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
OUTLINE Patients receive oral penicillamine on the following schedule Week 1 once daily Week 2 two times daily Week 3 three times daily Week 4 four times daily Week 5 to end of study increased dose four times daily Patients also receive oral pyridoxine daily and maintain a low copper diet no greater than 05 mgday This regimen is continued for up to 2 years in the absence of disease progression or unacceptable toxicity Radiotherapy is administered over 6 weeks beginning on day 1 of penicillamine therapy Patients are followed every month with MRI every 2 months until death
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| JHOC-NABTT-9704 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062475 |
| U01CA062475 | NIH | None | None |
| NABTT-9704 | None | None | None |