CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
90Y-hu3S193 +1 morebiological
Likely dose
10 mg hu3S193 radiolabeled with yttrium-90 (dose in mCi escalated per cohort)AI-extracted
Key inclusion· 5
  • ✓Histologically confirmed non-mucinous ovarian adenocarcinoma
  • ✓Persistent or recurrent intraperitoneal cancer after platinum/taxane-based therapy for Stage 3 ovarian cancer
  • ✓Residual disease <2 cm
  • ✓Karnofsky performance status ≥70
Key exclusion· 7
  • ✕Active parenchymal disease (Stage IV FIGO)
  • ✕Symptomatic extra-abdominal metastases
  • ✕CNS tumor involvement
  • ✕Clinically significant heart disease (NYHA Class III or IV)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00072410
NCT00072410Phase 1Completed
CompareCT.gov

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

Ludwig Institute for Cancer Research·interventional·Posted Nov 6, 2003·Updated Oct 4, 2023

In Brief

A Phase 1 clinical trial evaluating 90Y-hu3S193 and 111In-hu3S193 for Ovarian Cancer. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2003
Enrollment StartNov 1, 2003
Primary CompletionMay 1, 2005
Study CompletionNov 15, 2006
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 22.7 years ago

Interventions

90Y-hu3S193biological

Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.

111In-hu3S193biological

Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.