Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003023
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Trial of A1G4 Anti-Idiotypic Monoclonal Antibody With Bacille-Calmette-Guerin BCG Adjuvant in High Risk Patients With GD2 Positive Tumors
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:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining monoclonal antibody A1G4 with BCG may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer
Detailed Description:
OBJECTIVES
Assess the toxicity and feasibility of immunizing patients with anti-idiotypic rat monoclonal antibody A1G4 combined with Bacillus Calmette Guerin BCG adjuvant
Determine whether immunization with A1G4 combined with BCG results in an immune response directed against GD2 ganglioside in patients
OUTLINE All patients are treated with A1G4 diluted in sterile physiologic saline mixed with Bacillus Calmette Guerin BCG organisms The vaccine is injected intradermally in multiple sites Booster immunizations are administered during weeks 2 4 8 12 20 28 36 44 52 Immunizations are not administered in limbs where draining lymph nodes have been surgically removed or previously irradiated Isoniazid is administered for 5 days after each BCG injection If severe skin reactions are present at the injection site the BCG dose is decreased If skin reactions persist the BCG dose is stopped but A1G4 injections continue
At least 6 patients are accrued at each dose level of A1G4 Dose escalation is not carried out until patients have been followed for at least 8 weeks after the first immunization without encountering grade 3 or worse non-skin toxicity
If 0-1 patient experiences dose limiting toxicity DLT at a given dose level then patients are accrued to the next higher dose level If 2 or more patients experience DLT the MTD is defined as the previous dose level
Patients are followed for at least 1 year
PROJECTED ACCRUAL A total of 24 patients are expected to complete this study If patients are removed early from the study prior to evaluation for serological response additional patients will be accrued until 6 patients are evaluable for serological response
Assess the toxicity and feasibility of immunizing patients with anti-idiotypic rat monoclonal antibody A1G4 combined with Bacillus Calmette Guerin BCG adjuvant
Determine whether immunization with A1G4 combined with BCG results in an immune response directed against GD2 ganglioside in patients
OUTLINE All patients are treated with A1G4 diluted in sterile physiologic saline mixed with Bacillus Calmette Guerin BCG organisms The vaccine is injected intradermally in multiple sites Booster immunizations are administered during weeks 2 4 8 12 20 28 36 44 52 Immunizations are not administered in limbs where draining lymph nodes have been surgically removed or previously irradiated Isoniazid is administered for 5 days after each BCG injection If severe skin reactions are present at the injection site the BCG dose is decreased If skin reactions persist the BCG dose is stopped but A1G4 injections continue
At least 6 patients are accrued at each dose level of A1G4 Dose escalation is not carried out until patients have been followed for at least 8 weeks after the first immunization without encountering grade 3 or worse non-skin toxicity
If 0-1 patient experiences dose limiting toxicity DLT at a given dose level then patients are accrued to the next higher dose level If 2 or more patients experience DLT the MTD is defined as the previous dose level
Patients are followed for at least 1 year
PROJECTED ACCRUAL A total of 24 patients are expected to complete this study If patients are removed early from the study prior to evaluation for serological response additional patients will be accrued until 6 patients are evaluable for serological response
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 |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| MSKCC-97024 | None | None | None |
| NCI-G97-1268 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |