Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002664
Status:
WITHDRAWN
Last Update Posted:
2017-07-13
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
James Ahlgren
Organization:
George Washington University
Study Overview
Official Title:
PHASE II STUDY OF MONOCLONAL ANTIBODY 17-1A WITH GM-CSF IN TREATMENT OF 5-FU RESISTANT COLORECTAL CANCER
Status:
WITHDRAWN
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No recruitment
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 locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy plus G-CSF in treating patients with metastatic colorectal cancer that has not responded to treatment with fluorouracil
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy plus G-CSF in treating patients with metastatic colorectal cancer that has not responded to treatment with fluorouracil
Detailed Description:
OBJECTIVES I Assess the response rate duration of response and survival after treatment with monoclonal antibody 17-1A and granulocyte-macrophage colony stimulating factor in patients with colorectal cancer metastatic to nonhepatic sites and refractory to fluorouracil II Describe the toxicities associated with this regimen III Assess the quality of life in these patients
OUTLINE Biological Response Modifier Therapy Colorectal antigen 17-1A murine monoclonal antibody MOAB 17-1A NSC-377963 Granulocyte-macrophage colony stimulating factor Immunex GM-CSF NSC-613795
PROJECTED ACCRUAL There will be 30 evaluable patients accrued into this study over approximately 1 year
OUTLINE Biological Response Modifier Therapy Colorectal antigen 17-1A murine monoclonal antibody MOAB 17-1A NSC-377963 Granulocyte-macrophage colony stimulating factor Immunex GM-CSF NSC-613795
PROJECTED ACCRUAL There will be 30 evaluable patients accrued into this study over approximately 1 year
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-V95-0686 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064248 | REGISTRY | None | None |