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

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020410

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 I

Study Type:	Interventional
Study Design:	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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Filgrastim Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Claude Sportes, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068405, NCI-00-C-0206, NCI-213
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00020410 History of Changes
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:

Antibodies, Monoclonal
Antibodies
Neoplasms
Neoplasms by Site
Immunologic Factors
Skin Diseases

Physiological Effects of Drugs
Breast Neoplasms
Pharmacologic Actions
Breast Diseases
Immunoglobulins

ClinicalTrials.gov processed this record on November 27, 2009