Phase 1
N=7
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00072410 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Patients With Dose-limiting Toxicities (DLTs) — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 90Y-hu3S193 (Biological); 111In-hu3S193 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- May 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dose-limiting Toxicities (DLTs) |
0; 0 | — |
| SECONDARY Clearance as Measured by the Half-life (T1/2) of the Elimination Phase |
2.43; 2.28 | — |
| SECONDARY Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment |
0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00072410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.