Radiolabeled Monoclonal Antibody Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or
      deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell
      transplantation may be able to replace immune cells that were destroyed by therapy used to
      kill tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus
      peripheral stem cell transplantation in treating patients who have refractory or recurrent
      ovarian epithelial cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the normal organ and tumor dosimetry with yttrium Y 90 monoclonal
      antibody MN-14 using indium In 111 monoclonal antibody MN-14 as pretherapy in patients with
      advanced ovarian epithelial cancer. II. Evaluate the extent and duration of antitumor
      response in these patients on this regimen.

      OUTLINE: This is a dose escalation study of yttrium Y 90 monoclonal antibody MN-14 (90Y
      hMN-14). Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days -17 to -13, followed
      by leukapheresis on days -14 to -12. If an adequate number of CD34+ cells are not harvested,
      bone marrow is also collected. Patients receive pretherapy targeting consisting of indium In
      111 monoclonal antibody MN-14 over 30 minutes on day -7. At least 1 confirmed tumor site must
      be targeted. Patients receive 90Y hMN-14 IV over 30-45 minutes on day 0. PBSC is reinfused
      within 7 to 14 days after 90 hMN-14 administration. Patients receive G-CSF SQ or IV until
      blood counts recover. Cohorts of 3-6 patients receive escalating doses of 90Y hMN-14 until
      the maximum tolerated dose (MTD) is determined. The MTD is defined as either the dose at
      which no more than 1 of 6 patients experiences dose limiting toxicity or the threshold
      radiation doses to lungs, kidney, and liver are reached. Patients are followed weekly for 1
      month, every 2 weeks for 2 months, monthly for 3 months, every 3 months for 2 years, and then
      every 6 months for 5 years.

      PROJECTED ACCRUAL: Approximately 48-51 patients will be accrued for this study within 5
      years.
    

Intervention name(s): filgrastim; peripheral blood stem cell transplantation; indium In 111 monoclonal antibody MN-14; yttrium Y 90 monoclonal antibody MN-14
Intervention type(s): Biological; Procedure; Radiation; Radiation
Intervention description(s): as prescribed by physician; 1-2 weeks from treatment; intravenous infusion over 30 min; single dose; intravenous infusion over 30 min; single dose
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer