Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072410
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2003-11-04
Brief Title:
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Single-Dose Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Humanized Monoclonal Antibody 3S193 90Y-hu3S193 in Patients With Advanced Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2023-10
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 Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells Giving radiolabeled monoclonal antibody directly into the abdominal cavity may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody therapy directly into the abdominal cavity in treating patients who have advanced ovarian epithelial cancer
PURPOSE Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody therapy directly into the abdominal cavity in treating patients who have advanced ovarian epithelial cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and maximum tolerated dose of intraperitoneally IP administered yttrium-90 90Y radiolabeled monoclonal antibody mAB hu3S193 90Y-hu3S193 in patients with advanced ovarian epithelial cancer
Secondary
Determine the localization and whole body and abdominal clearance of 90Y-hu3S193 using indium-111 111In radiolabeled hu3S193 and gamma camera imaging
Determine the serum pharmacokinetics of hu3S193 using gamma well counting
Determine the antibody response as measured by human anti-human antibody response HAHA
OUTLINE This is a dose-escalation study of the yttrium-90 radiolabeled monoclonal antibody 90Y-hu3S193
Patients received technetium 99mTc-sulfur colloid IP and underwent abdominal imaging on day 1 Provided the distribution of the 99mTC-sulfur colloid was deemed adequate patients then received 90Y-hu3S193 IP 111In-hu3S193 was also administered IP over 30 minutes on day 1 to enable gamma camera imaging Within 3-5 hours after antibody administration patients underwent whole body imaging and single-photon emission-computed tomography SPECT imaging of the abdomen and pelvis
Cohorts of 3-6 patients were to receive escalating doses of 90Y-hu3S193 until the maximum tolerated dose MTD was determined The MTD was defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients were to be followed every 3 months for at least 2 years and then every 6 months for up to 5 years
Primary
Determine the safety and maximum tolerated dose of intraperitoneally IP administered yttrium-90 90Y radiolabeled monoclonal antibody mAB hu3S193 90Y-hu3S193 in patients with advanced ovarian epithelial cancer
Secondary
Determine the localization and whole body and abdominal clearance of 90Y-hu3S193 using indium-111 111In radiolabeled hu3S193 and gamma camera imaging
Determine the serum pharmacokinetics of hu3S193 using gamma well counting
Determine the antibody response as measured by human anti-human antibody response HAHA
OUTLINE This is a dose-escalation study of the yttrium-90 radiolabeled monoclonal antibody 90Y-hu3S193
Patients received technetium 99mTc-sulfur colloid IP and underwent abdominal imaging on day 1 Provided the distribution of the 99mTC-sulfur colloid was deemed adequate patients then received 90Y-hu3S193 IP 111In-hu3S193 was also administered IP over 30 minutes on day 1 to enable gamma camera imaging Within 3-5 hours after antibody administration patients underwent whole body imaging and single-photon emission-computed tomography SPECT imaging of the abdomen and pelvis
Cohorts of 3-6 patients were to receive escalating doses of 90Y-hu3S193 until the maximum tolerated dose MTD was determined The MTD was defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients were to be followed every 3 months for at least 2 years and then every 6 months for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| LUD2001-018 | OTHER | Ludwig Institute for Cancer Research | None |
| MSKCC-03069 | OTHER | None | None |