Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	Any age	NCI	MSKCC-03069 LUDWIG-LUD01-018, NCT00072410

Objectives

Primary

1. 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

1. 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.
2. Determine the serum pharmacokinetics of Y90 MOAB Hu3S193 in these patients using gamma well counting.
3. Determine the antibody response in patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age

• Any age

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

• FEV₁ 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Chaitanya Divgi, MD, Principal investigator(Contact information may not be current)		Ph: 212-639-8895; 800-525-2225

Registry Information
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
Trial Start Date		2003-06-25
Registered in ClinicalTrials.gov		NCT00072410
Date Submitted to PDQ		2003-09-30
Information Last Verified		2005-08-18
NCI Grant/Contract Number		P30-CA08748

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