TheranosticTrials.org

Clinical Trial · NCT00020410

Radiolabeled Monoclonal Antibody Followed by Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Metastatic Breast Cancer

Overview

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 allow the doctor to give higher doses of monoclonal antibody therapy and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody followed by peripheral stem cell transplantation in treating patients who have relapsed or metastatic breast cancer.

Sponsor

National Cancer Institute

Phase

Phase 1

Contacts

Claude Sportes, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00020410

Drug / Compound

monoclonal antibody B3

Isotope(s):
Target(s):
  • Lewis Y antigen
Ligand Class: Antibodies
Chelator: DTPA
Linker: 2-(p-isothiocyanatobenzyl)-6-methyl

monoclonal antibody B3

Isotope(s):
Target(s):
  • Lewis Y antigen
Ligand Class: Antibodies
Chelator: DTPA
Linker: 2-(p-isothiocyanatobenzyl)-6-methyl

Eligibility

Inclusion

  • Tumor tissue must express B3 antigen on the surface of more than 30% of tumor cells
  • At least 4 weeks since prior hormonal therapy
  • DLCO at least 55% of predictedOther:
  • Absolute granulocyte count greater than 2,000/mm\^3
  • Creatinine no greater than 1.4 mg/dLCardiovascular:
  • Negative pregnancy test
  • At least 1 site of relapse or metastatic disease
  • At least 4 weeks since prior local radiotherapy to one site and recovered
  • Hormone receptor status:
  • PT normal
  • One regimen must contain an anthracycline and a taxane as adjuvant therapy or for metastatic disease
  • FVC at least 55% of predicted
  • Fertile patients must use effective contraceptionBiologic therapy:
  • Progressive disease after at least 1 prior chemotherapy regimen for metastatic disease
  • Male or femaleMenopausal status:
  • Prior adjuvant chemotherapy allowed
  • HIV negative
  • Ejection fraction at least 45% by MUGA or echocardiogramPulmonary:
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • Measurable or evaluable disease
  • ECOG 0-1Life expectancy:
  • 18 and overSex:
  • Platelet count greater than 100,000/mm\^3Hepatic:
  • SGOT and SGPT no greater than 2 times upper limit of normal
  • Hepatitis C negativeRenal:
  • Histologically or cytologically confirmed stage IV breast cancer
  • Hepatitis B surface antigen negative
  • FEV\_1 greater than 60% of predicted
  • Bilirubin normal

Exclusion

  • No prior high-dose chemotherapy with bone marrow or stem cell transplantationEndocrine therapy:
  • Not pregnant or nursing
  • No known seizure disorders
  • No prior mouse antibodyChemotherapy:
  • Not specifiedOther:
  • No CNS metastasis
  • Not specifiedPerformance status:
  • Not specifiedHematopoietic:
  • No concurrent chronic steroidsRadiotherapy:
  • No prior radiotherapy to the pelvis and/or spineSurgery:
  • No concurrent anticoagulants
  • No other concurrent medical or psychiatric condition that would preclude study participation
  • No history of autoimmune disease