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Phase I/II Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 in Advanced Ovarian Cancer Using Autologous Peripheral Blood Stem Cell Rescue (PBSCR) to Control Myelotoxicity


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

Phase I/II Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 in Advanced Ovarian Cancer Using Autologous Peripheral Blood Stem Cell Rescue (PBSCR) to Control Myelotoxicity


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically refractory or recurrent ovarian
epithelial cancer Resistant to platinum or taxane containing chemotherapy within past 6
months Autologous peripheral blood stem cells (PBSC) or bone marrow available At least 1
measurable site confirmed by CT targeted pretherapy indium In 111 monoclonal antibody
MN-14 imaging No bone marrow involvement

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 70-100% ECOG 0-2 Life
expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at
least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0
mg/dL SGOT less than 2.0 times upper limit of normal (ULN) Renal: Creatinine less than 1.5
times ULN Creatinine clearance at least 50 mL/min Cardiovascular: LVEF at least 50% by
MUGA Pulmonary: FVC, FEV1, and DLCO at least 70% of predicted Other: Not pregnant Fertile
patients must use effective contraception during and for 3 months after study No
AIDS-related illness No concurrent significant medical complications that would preclude
compliance No severe anorexia, nausea, or vomiting No history of allergy or antibodies to
90Y hMN-14

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior imaging studies with murine
monoclonal antibodies showing reactivity with yttrium Y 90 monoclonal antibody MN-14 (90Y
hMN-14) Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine
therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to index
lesion and recovered No prior radiotherapy to greater than 25% of red marrow No prior
radiotherapy to maximum tolerated levels for any critical organ (e.g., lung, liver, or
kidney) Surgery: At least 4 weeks since prior major surgery Other: No concurrent
antiretroviral medication

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Jack D. Burton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067299

NCT ID:

NCT00004177

Start Date:

August 1999

Completion Date:

Related Keywords:

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

Name

Location
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Garden State Cancer Center Belleville, New Jersey  07103