NCT00072410

Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Ludwig Institute for Cancer Research · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	90Y-hu3S193	Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
BIOLOGICAL	111In-hu3S193	Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-05-01
• Completion: 2006-11-15
• First posted: 2003-11-06
• Last updated: 2023-10-04
• Results posted: 2021-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study