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Trial record 5 of 7 for:    hu3s193

Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial 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: NCT00072410
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : February 9, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Radiation: yttrium Y 90 monoclonal antibody Hu3S193 Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: 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
Study Start Date : June 2003






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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

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): 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

ClinicalTrials.gov Identifier: NCT00072410     History of Changes
Other Study ID Numbers: CDR0000339682
MSKCC-03069
LUDWIG-LUD01-018
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: August 2005

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs