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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006099
Recruitment Status : Terminated (low study accrual)
First Posted : December 23, 2003
Results First Posted : August 12, 2021
Last Update Posted : August 12, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: Monoclonal antibody hu3S193 Phase 1

Detailed Description:

OBJECTIVES: The primary objective iss to determine the safety of indium (111In) monoclonal antibody (mAb) hu3S193 (111In-hu3S193) given intraperitoneally or intravenously in patients with ovarian carcinoma.

Secondary objectives include comparing the localization of 111In-hu3S193 in ovarian cancer tissue after intraperitoneal vs intravenous injection and the biodistribution and pharmacokinetics of this drug when administered intraperitoneally vs intravenously in these patients as well as the formation of human anti-human antibodies (HAHA) in these patients.

OUTLINE: Patients are assigned to 1 of 2 treatment arms on a first come sequential basis. Arm I: Patients receive indium (In 111) monoclonal antibody hu3S193 (111In-hu3S193) intraperitoneally over 30 minutes. Arm II: Patients received 111In-hu3S193 intravenously (IV) over 30 minutes. Patients were to undergo surgical debulking 3-7 days following In 111In-hu3S193 administration, and biopsy samples obtained to assess radioactive uptake. Immunohistochemistry was also to be performed. Blood samples were to be obtained to assess serum radioactivity. Whole body imaging was tp be performed 3 hours after infusion of radiolabeled monoclonal antibody, on the day of surgery, and at one time point in between. Patients were followed for 30 days.

PROJECTED ACCRUAL: A total of 10 patients (5 per arm) were to be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Trial of Humanized 3S193 Monoclonal Antibody (hu3S193) in Presurgical Patients With Ovarian Cancer
Actual Study Start Date : August 2, 2000
Actual Primary Completion Date : February 26, 2002
Actual Study Completion Date : August 12, 2002


Arm Intervention/treatment
Experimental: Intraperitoneal (IP) Infusion of 111In-hu3S193

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

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




Primary Outcome Measures :
  1. Number of Subjects With Grade 3 Adverse Events [ Time Frame: up to 30 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   ovarian carcinoma patients
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006099


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
National Cancer Institute (NCI)
Investigators
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Study Chair: Chaitanya R. Divgi, MD Memorial Sloan Kettering Cancer Center
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Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00006099    
Other Study ID Numbers: CDR0000068107
MSKCC-00047 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
NCI-G00-1828 ( Other Identifier: National Cancer Institute )
LUD1998-013 ( Other Identifier: Ludwig Institute for Cancer Research )
First Posted: December 23, 2003    Key Record Dates
Results First Posted: August 12, 2021
Last Update Posted: August 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ludwig Institute for Cancer Research:
ovarian epithelial cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs