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Phase I Study Of Yttrium 90-Labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Phase I Study Of Yttrium 90-Labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Claude Sportes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068405

NCT ID:

NCT00020410

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Center for Cancer ResearchBethesda, Maryland  20892