Breast CancerPhase 1NCT00020410
Radiolabeled Monoclonal Antibody Followed by Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Metastatic Breast Cancer
A Phase 1 study testing filgrastim, peripheral blood stem cell transplantation and yttrium Y 90 monoclonal antibody B3 in people with Breast Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, peripheral blood stem cell transplantation and yttrium Y 90 monoclonal antibody B3
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Feb 2001to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Center for Cancer Research
Bethesda, Maryland, 20892
About this study
Official title: Phase I Study Of Yttrium 90-labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, peripheral blood stem cell transplantation, yttrium Y 90 monoclonal antibody B3
- Keywords
- stage IV breast cancer, recurrent breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
peripheral blood stem cell transplantationProcedure or surgery
yttrium Y 90 monoclonal antibody B3Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Claude Sportes, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020410
- Sponsor's protocol ID
- CDR0000068405
- Other IDs
- NCI-00-C-0206, NCI-213
- Status last verified
- Sep 2003
- First submitted
- 11 Jul 2001
- Last updated
- 30 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of Yttrium 90-labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00020410
- Acronym / sponsor ID
- CDR0000068405
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, male breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| yttrium Y 90 monoclonal antibody B3 | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Sportes, MD study chair
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing filgrastim, peripheral blood stem cell transplantation and yttrium Y 90 monoclonal antibody B3 in people with Breast Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.