Completed

Single-Dose, Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Humanized Monoclonal Antibody 3S193 (90Y-hu3S193) in Patients With Advanced Ovarian Cancer

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What is being tested

90Y-hu3S193

+ 111In-hu3S193

Biological
Who is being recruted

Carcinoma, Ovarian Epithelial+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorLudwig Institute for Cancer Research
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleSingle-Dose, Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Humanized Monoclonal Antibody 3S193 (90Y-hu3S193) in Patients With Advanced Ovarian Cancer 
NCT00072410
Principal SponsorLudwig Institute for Cancer Research
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Carcinoma, Ovarian EpithelialUrogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

Inclusion Criteria 1. Histologically confirmed non-mucinous ovarian adenocarcinoma. 2. Persistent or recurrent intraperitoneal cancer following platinum/taxane-based therapy for Stage 3 ovarian cancer. 3. Patients with residual disease \< 2cm will be candidates for this study. 4. The following laboratory and clinical results within the last 2 weeks prior to study day 1: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; Platelet count ≥ 100 x 10\^9/L; Serum bilirubin ≤ 2.0 mg/dL; Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 2.5 x ULN; Serum creatinine ≤2.0 mg/dL; Forced expiratory volume (FEV1) ≥60% of predicted; Forced vital capacity (FVC) ≥60% of predicted; Diffusion capacity ≥55% of predicted; Left ventricular ejection fraction (LVEF) ≥50%; 5. Karnofsky performance status ≥ 70. 6. Before any trial-specific procedures or treatment can be performed, the patient or legally authorized guardian or representative must give witnessed written informed consent for participation in the trial. 7. Placement of an intra-abdominal catheter at the time of surgery. Exclusion Criteria 1. Active parenchymal disease (i.e., Stage IV International Federation of Gynecology and Obstetrics (FIGO) classification). 2. Presence of symptomatic extra abdominal metastases. 3. Known central nervous system (CNS) tumor involvement. 4. Clinically significant heart disease (New York Heart Association Class III or IV). 5. ECG demonstrating clinically significant arrhythmias or evidence of prior myocardial infarction. 6. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders that may limit the amount of antibody they can tolerate or render them ineligible for surgery. 7. Chronic inflammatory bowel disease. 8. Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior to enrollment. 9. Pregnancy or lactation. 10. Patients who are positive for human anti-human antibodies (HAHA) and/or who have received a murine monoclonal antibody.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5mCi 111In-hu3S193 to enable imaging after dosing.

Group II

Experimental
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5mCi 111In-hu3S193 to enable imaging after dosing.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Memorial Sloan-Kettering Cancer Center

New York, United StatesSee the location
CompletedOne Study Center