Status:
COMPLETED
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 dire...
Detailed Description
OBJECTIVES: Primary * Determine the safety and maximum tolerated dose of intraperitoneally (IP) administered yttrium-90 (90Y) radiolabeled monoclonal antibody (mAB) hu3S193 (90Y-hu3S193) in patients...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically confirmed non-mucinous ovarian adenocarcinoma.
- Persistent or recurrent intraperitoneal cancer following platinum/taxane-based therapy for Stage 3 ovarian cancer.
- Patients with residual disease \< 2cm will be candidates for this study.
- The following laboratory and clinical results within the last 2 weeks prior to study day 1:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; Platelet count ≥ 100 x 10\^9/L; Serum bilirubin ≤ 2.0 mg/dL; Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 2.5 x ULN; Serum creatinine ≤2.0 mg/dL; Forced expiratory volume (FEV1) ≥60% of predicted; Forced vital capacity (FVC) ≥60% of predicted; Diffusion capacity ≥55% of predicted; Left ventricular ejection fraction (LVEF) ≥50%;
- Karnofsky performance status ≥ 70.
- Before any trial-specific procedures or treatment can be performed, the patient or legally authorized guardian or representative must give witnessed written informed consent for participation in the trial.
- Placement of an intra-abdominal catheter at the time of surgery.
- Exclusion Criteria
- Active parenchymal disease (i.e., Stage IV International Federation of Gynecology and Obstetrics (FIGO) classification).
- Presence of symptomatic extra abdominal metastases.
- Known central nervous system (CNS) tumor involvement.
- Clinically significant heart disease (New York Heart Association Class III or IV).
- ECG demonstrating clinically significant arrhythmias or evidence of prior myocardial infarction.
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders that may limit the amount of antibody they can tolerate or render them ineligible for surgery.
- Chronic inflammatory bowel disease.
- Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior to enrollment.
- Pregnancy or lactation.
- Patients who are positive for human anti-human antibodies (HAHA) and/or who have received a murine monoclonal antibody.
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2006
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00072410
Start Date
November 1 2003
End Date
November 15 2006
Last Update
October 4 2023
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021