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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020410
First received: July 11, 2001
Last updated: February 6, 2009
Last verified: September 2003
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Procedure: peripheral blood stem cell transplantation
Radiation: yttrium Y 90 monoclonal antibody B3
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study Of Yttrium 90-Labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody B3 followed by autologous peripheral blood stem cell transplantation in patients with relapsed or metastatic breast cancer.
  • Determine the toxicity of this treatment regimen in these patients.
  • Determine the clinical response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody B3 (Y90 MOAB B3).

Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 4 days prior to peripheral blood stem cell (PBSC) collection and continuing until the target number of cells is reached.

After PBSC collection, patients receive indium In 111 monoclonal antibody B3 IV over 30-60 minutes once within days -7 to -1 for tumor imaging and then Y90 MOAB B3 IV over 30-60 minutes on day 0. After at least day 7, patients undergo autologous PBSC reinfusion. Patients receive G-CSF SC daily beginning 7 days after PBSC reinfusion and continuing until blood counts recover.

Cohorts of 3-6 patients receive escalating doses of Y90 MOAB B3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 week, 1 month, and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 24-36 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IV breast cancer

    • At least 1 site of relapse or metastatic disease
  • Progressive disease after at least 1 prior chemotherapy regimen for metastatic disease

    • One regimen must contain an anthracycline and a taxane as adjuvant therapy or for metastatic disease
    • Prior adjuvant chemotherapy allowed
  • Measurable or evaluable disease
  • Tumor tissue must express B3 antigen on the surface of more than 30% of tumor cells
  • No CNS metastasis
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • SGOT and SGPT no greater than 2 times upper limit of normal
  • PT normal
  • Hepatitis B surface antigen negative
  • Hepatitis C negative

Renal:

  • Creatinine no greater than 1.4 mg/dL

Cardiovascular:

  • Ejection fraction at least 45% by MUGA or echocardiogram

Pulmonary:

  • FEV_1 greater than 60% of predicted
  • FVC at least 55% of predicted
  • DLCO at least 55% of predicted

Other:

  • No known seizure disorders
  • No history of autoimmune disease
  • No other active malignancy except previously treated basal cell skin cancer
  • No other concurrent medical or psychiatric condition that would preclude study participation
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Chemotherapy
  • No prior mouse antibody

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No prior high-dose chemotherapy with bone marrow or stem cell transplantation

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • No concurrent chronic steroids

Radiotherapy:

  • At least 4 weeks since prior local radiotherapy to one site and recovered
  • No prior radiotherapy to the pelvis and/or spine

Surgery:

  • Not specified

Other:

  • No concurrent anticoagulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020410

Locations
United States, Maryland
Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Claude Sportes, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00020410     History of Changes
Obsolete Identifiers: NCT00006197
Other Study ID Numbers: CDR0000068405, NCI-00-C-0206, NCI-213
Study First Received: July 11, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 20, 2014