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


Phase 1
N/A
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Chaitanya R. Divgi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000339682

NCT ID:

NCT00072410

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021