Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052624
Status:
UNKNOWN
Last Update Posted:
2018-05-15
First Post:
2003-01-24
Brief Title:
Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma
Sponsor:
Xenova Biomedix
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Multicenter Trial Of IntratumoralInterstitial Therapy With HN66000 NC66000 TransMID In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma
Status:
UNKNOWN
Status Verified Date:
2004-04
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 Immunotoxins can locate tumor cells and kill them without harming normal cells Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic astrocytoma
PURPOSE Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
PURPOSE Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric patients with progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
Determine the safety of this drug in these patients
Determine the efficacy of this drug in these patients
Compare the efficacy of this drug in patients with different histological types of tumor degrees of transferrin receptor expression and serum antidiphtheria antibody titer levels
OUTLINE This is a dose-escalation open-label multicenter study Patients are assigned to 1 of 2 treatment groups by age 5-9 vs 10-18
All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2 intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 Tf-CRM107
Group 1 ages 5-9 Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity Three cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum tolerated dose MTD is determined
Group 2 ages 10-18 Patients receive intratumoral Tf-CRM107 as in group 1 Two cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined
The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 6 months and then every 3 months for 6 months
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric patients with progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
Determine the safety of this drug in these patients
Determine the efficacy of this drug in these patients
Compare the efficacy of this drug in patients with different histological types of tumor degrees of transferrin receptor expression and serum antidiphtheria antibody titer levels
OUTLINE This is a dose-escalation open-label multicenter study Patients are assigned to 1 of 2 treatment groups by age 5-9 vs 10-18
All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2 intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 Tf-CRM107
Group 1 ages 5-9 Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity Three cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum tolerated dose MTD is determined
Group 2 ages 10-18 Patients receive intratumoral Tf-CRM107 as in group 1 Two cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined
The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 6 months and then every 3 months for 6 months
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000258574 | REGISTRY | PDQ Physician Data Query | None |
| KSB-311PCI001 | None | None | None |