Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002754
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Melanoma or Brain Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
PHASE I STUDY OF MONOCLONAL ANTIBODY FRAGMENT 131I MEL-14 FAB2 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT MELANOMA AND OTHER BRAIN TUMORS
Status:
COMPLETED
Status Verified Date:
2013-02
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
PURPOSE Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors
PURPOSE Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of iodine-131-labeled monoclonal antibody fragment ME1-14 Fab2 administered intracystically in patients with recurrent or newly diagnosed primary or metastatic malignant melanoma or other brain tumors II Identify any objective therapeutic responses to this treatment
OUTLINE All patients receive a fixed dose of monoclonal antibody fragment ME1-14 Fab2 via an intralesional catheter cohorts of 3-6 patients receive escalating doses of isotope conjugated to the antibody until the maximum tolerated dose is determined Patients with newly diagnosed disease at entry may receive additional therapy with external-beam radiotherapy beginning 4 months after radioimmunotherapy or sooner if disease progression occurs Patients with recurrent disease at entry are followed without further therapy for at least 4 months after radioimmunotherapy alternative therapy may be offered upon progression All patients are followed at 4 8 16 and 24 weeks after treatment then every 12 weeks for 1 year
PROJECTED ACCRUAL Three to six patients will be entered at each dose studied
OUTLINE All patients receive a fixed dose of monoclonal antibody fragment ME1-14 Fab2 via an intralesional catheter cohorts of 3-6 patients receive escalating doses of isotope conjugated to the antibody until the maximum tolerated dose is determined Patients with newly diagnosed disease at entry may receive additional therapy with external-beam radiotherapy beginning 4 months after radioimmunotherapy or sooner if disease progression occurs Patients with recurrent disease at entry are followed without further therapy for at least 4 months after radioimmunotherapy alternative therapy may be offered upon progression All patients are followed at 4 8 16 and 24 weeks after treatment then every 12 weeks for 1 year
PROJECTED ACCRUAL Three to six patients will be entered at each dose studied
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-V96-1071 | None | None | None |
| DUMC-0334-99-2R6 | None | None | None |
| DUMC-219-96-2R3 | None | None | None |
| DUMC-302-97-2R4 | None | None | None |
| DUMC-308-98-2R5 | None | None | None |