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Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

This study has been completed.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072410
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: yttrium Y 90 monoclonal antibody Hu3S193
Phase I

MedlinePlus related topics:   Cancer    Ovarian Cancer   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   June 2003

Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and maximum tolerated dose of intraperitoneal yttrium Y 90 monoclonal antibody Hu3S193 (Y90 MOAB Hu3S193) in patients with advanced ovarian epithelial cancer.

Secondary

  • Determine the localization and whole body and abdominal clearance of this drug in these patients using indium In 111 monoclonal antibody Hu3S193 and gamma camera imaging.
  • Determine the serum pharmacokinetics of Y90 MOAB Hu3S193 in these patients using gamma well counting.
  • Determine the antibody response in patients treated with this drug.

OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Hu3S193 (Y90 MOAB Hu3S193).

Patients receive intraperitoneal (IP) technetium Tc 99m sulfur colloid and undergo abdominal imaging on day 1. Provided distribution of technetium Tc 99m sulfur colloid is deemed adequate, patients then receive IP Y90 MOAB Hu3S193 and IP indium In 111 monoclonal antibody Hu3S193 (for imaging) over 30 minutes on day 1. Within 3-5 hours after antibody administration, patients undergo whole body imaging and single-photon emission-computed tomography (SPECT) imaging of the abdomen and pelvis.

Cohorts of 3-6 patients receive escalating doses of Y90 MOAB Hu3S193 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for at least 2 years and then every 6 months for up to 5 years.

PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-mucinous ovarian adenocarcinoma
  • Persistent or recurrent intraperitoneal disease after platinum/taxane-based therapy for stage III ovarian cancer
  • No active parenchymal disease (stage IV)
  • No symptomatic extraabdominal metastases
  • No known CNS tumor involvement

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No bleeding disorders

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • LVEF at least 50%
  • No New York Heart Association class III or IV heart disease
  • No clinically significant arrhythmia by ECG
  • No evidence of prior myocardial infarction

Pulmonary

  • FEV_1 at least 60% of predicted
  • FVC at least 60% of predicted
  • Diffusion capacity at least 55% of predicted

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No other serious illness that would preclude study participation
  • No serious infection requiring antibiotics
  • No chronic inflammatory bowel disease
  • Human antimouse antibody negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior biologic therapy
  • More than 4 weeks since prior immunotherapy
  • No prior murine monoclonal antibody therapy

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No immunosuppressive therapy for 30 days after the administration of yttrium Y 90 monoclonal antibody Hu3S193
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072410

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Chaitanya R. Divgi, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000339682, MSKCC-03069, LUDWIG-LUD01-018
First Received:   November 4, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00072410
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer  
stage III ovarian epithelial cancer  

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Recurrence
Genital Diseases, Female
Antibodies, Monoclonal
Antibodies
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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