NCT00072410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2006

Completed
15.1 years until next milestone

Results Posted

Study results publicly available

December 21, 2021

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

November 4, 2003

Results QC Date

November 23, 2021

Last Update Submit

October 2, 2023

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancerstage III ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Dose-limiting Toxicities (DLTs)

    All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT was defined as: * Any Grade 3 or greater non-hematological toxicity (except for alopecia, nausea, and vomiting, defined separately below) * Any Grade alopecia * Grade 4 nausea or vomiting ≥ 5 days duration. * Any Grade 4 hematological toxicity (except for toxicity of ≤ 5 days duration without growth factor, platelet, or transfusion support). To be dose limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.

    Up to day 56

Secondary Outcomes (2)

  • Clearance as Measured by the Half-life (T1/2) of the Elimination Phase

    Up to 22 days

  • Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment

    Up to day 56

Study Arms (2)

Cohort 1

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.

Biological: 90Y-hu3S193Biological: 111In-hu3S193

Cohort 2

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.

Biological: 90Y-hu3S193Biological: 111In-hu3S193

Interventions

90Y-hu3S193BIOLOGICAL

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

Also known as: humanized monoclonal antibody 3S193 radiolabeled with 90Y
Cohort 1Cohort 2
111In-hu3S193BIOLOGICAL

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

Also known as: humanized monoclonal antibody 3S193 radiolabeled with 111In
Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-mucinous ovarian adenocarcinoma.
  • Persistent or recurrent intraperitoneal cancer following platinum/taxane-based therapy for Stage 3 ovarian cancer.
  • Patients with residual disease \< 2cm will be candidates for this study.
  • 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%;
  • Karnofsky performance status ≥ 70.
  • 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.
  • Placement of an intra-abdominal catheter at the time of surgery.

You may not qualify if:

  • Active parenchymal disease (i.e., Stage IV International Federation of Gynecology and Obstetrics (FIGO) classification).
  • Presence of symptomatic extra abdominal metastases.
  • Known central nervous system (CNS) tumor involvement.
  • Clinically significant heart disease (New York Heart Association Class III or IV).
  • ECG demonstrating clinically significant arrhythmias or evidence of prior myocardial infarction.
  • 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.
  • Chronic inflammatory bowel disease.
  • Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior to enrollment.
  • Pregnancy or lactation.
  • Patients who are positive for human anti-human antibodies (HAHA) and/or who have received a murine monoclonal antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

90Y-CHX-A''-DTPA-hu3S193Yttrium-90

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Jonathan Skipper PhD
Organization
Ludwig Institute for Cancer Research
jskipper@lcr.org
12124501539

Study Officials

  • Chaitanya R. Divgi, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2003

First Posted

November 6, 2003

Study Start

November 1, 2003

Primary Completion

May 1, 2005

Study Completion

November 15, 2006

Last Updated

October 4, 2023

Results First Posted

December 21, 2021

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)