Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023933
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2001-09-13
Brief Title:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of 131I-HuCC49CH2 for Colon Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 deleted CH2 region in patients with colorectal cancer
II Determine the toxic effects plasma pharmacokinetics whole body biodistribution and conjugate stability of this drug in these patients
III Determine the ability of this drug to localize to tumor sites in these patients
IV Determine the immune response in patients treated with this drug
OUTLINE This is a dose-escalation study
Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8
Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity
Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression
I Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 deleted CH2 region in patients with colorectal cancer
II Determine the toxic effects plasma pharmacokinetics whole body biodistribution and conjugate stability of this drug in these patients
III Determine the ability of this drug to localize to tumor sites in these patients
IV Determine the immune response in patients treated with this drug
OUTLINE This is a dose-escalation study
Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8
Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity
Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression
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 |
|---|---|---|---|
| CDR0000068877 | REGISTRY | PDQ Physician Data Query | None |
| UAB 9846 | None | None | None |