Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer

NCT00006099 | Terminated Phase 1 Results FDA Drug

• 4 other identifiers: CDR0000068107MSKCC-00047NCI-G00-1828LUD1998-013
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving monoclonal antibodies in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian cancer.

Conditions

Ovarian Cancer

Keywords

ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Grade 3 Adverse Events

  All toxicities were to be graded according to the Common Toxicity Criteria (CTC) Scale, version 2.0, March 1998.The study was to be terminated upon the occurrence of an adverse event of Grade 3 or greater severity that is considered definitely related to hu3S193.

  up to 30 days

Study Arms (2)

Intraperitoneal (IP) Infusion of 111In-hu3S193

EXPERIMENTAL

Hu3S193 was administered intraperitoneally at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In. Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline.

Biological: Monoclonal antibody hu3S193

Intravenous Infusion of 111In-hu3S193

EXPERIMENTAL

Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.

Biological: Monoclonal antibody hu3S193

Interventions

Monoclonal antibody hu3S193 BIOLOGICAL

Hu3S193 was to be administered intraperitoneally or intravenously at a dose of 5mg. Doses of hu3S193 were radiolabeled with 5 mCi of 111In.

Intraperitoneal (IP) Infusion of 111In-hu3S193; Intravenous Infusion of 111In-hu3S193

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: ovarian carcinoma patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologic or pathologic diagnosis consistent with ovarian carcinoma. Scheduled to undergo surgical evaluation. Karnofsky performance status of \> 60%.
• Adequate organ function as defined by:
• Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
• Platelet count \> 100 x 10\^9/L
• Bilirubin \< 2.0 mg/dL
• Aspartate aminotransferase (AST) and Alanine transaminase (ALT) \< 2.5 X upper limit of normal
• Serum creatinine \< 2.0 mg/dL
• Forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)\> 70% of predicted
• Left Ventricular Ejection Fraction \>50%
• Recovered from the toxicity of any prior therapy. No evidence of active infection which requires antibiotic therapy. \> 18 years of age. Able to sign written informed consent.

You may not qualify if:

• Any significant intercurrent medical problems which may limit the amount of antibody they can tolerate, or render them ineligible for surgery.
• Clinically significant cardiac disease (New York Heart Association Class III/IV, or abnormalities on ECG that are considered by the investigator to place the patient at increased risk), severe debilitating pulmonary disease, active infections or coagulation disorders.
• Survival expectancy less than 12 weeks. History of autoimmune hepatitis or history of autoimmune disease. Chemotherapy, radiotherapy, or immunotherapy within four weeks prior to receiving hu3S193.
• Psychiatric, addictive or other disorders that compromise the ability to give informed consent.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Hu3S193 monoclonal antibody

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: December 23, 2003
• Study Start: August 2, 2000
• Primary Completion: February 26, 2002
• Study Completion: August 12, 2002
• Last Updated: October 4, 2023
• Results First Posted: August 12, 2021

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)