Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	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	Radiation: yttrium Y 90 monoclonal antibody Hu3S193	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000339682, MSKCC-03069, LUDWIG-LUD01-018
Study First Received:	November 4, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00072410 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Physiological Effects of Drugs
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Pharmacologic Actions

Adnexal Diseases
Antibodies, Monoclonal
Genital Diseases, Female
Neoplasms
Antibodies
Neoplasms by Site
Endocrine Gland Neoplasms
Immunoglobulins

ClinicalTrials.gov processed this record on November 27, 2009