Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003543
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy Plus Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of Combination Immunochemotherapy in Patients With Advanced Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Monoclonal antibodies can find and locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy in treating patients with advanced colorectal cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy in treating patients with advanced colorectal cancer
Detailed Description:
OBJECTIVES I Define toxicity and the maximum tolerated dose of humanized monoclonal antibody A33 MOAB A33 when combined with carmustine fluorouracil vincristine and streptozocin in patients with advanced colorectal cancer II Determine the effect of chemotherapy on human antihuman antibody response and on the pharmacokinetics of humanized MOAB A33 in these patients III Define the humanized MOAB A33 dose for a phase II study
OUTLINE This is a dose escalation study of humanized monoclonal antibody A33 MOAB A33 Patients receive humanized MOAB A33 IV once a week for 14 weeks Chemotherapy begins on day 29 and consists of carmustine IV on days 29-33 fluorouracil IV on days 29-33 and 64-68 vincristine IV on days 29 and 64 and streptozocin IV every 7 days beginning on day 29 for 10 doses Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of humanized MOAB A33 The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL There will be 3-18 patients accrued into this study over 2-9 months
OUTLINE This is a dose escalation study of humanized monoclonal antibody A33 MOAB A33 Patients receive humanized MOAB A33 IV once a week for 14 weeks Chemotherapy begins on day 29 and consists of carmustine IV on days 29-33 fluorouracil IV on days 29-33 and 64-68 vincristine IV on days 29 and 64 and streptozocin IV every 7 days beginning on day 29 for 10 doses Courses repeat every 14 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of humanized MOAB A33 The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL There will be 3-18 patients accrued into this study over 2-9 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 |
|---|---|---|---|
| CDR0000066597 | REGISTRY | None | None |
| NCI-H98-0022 | Registry Identifier | PDQ Physician Data Query | None |