Breast CancerPhase 1NCT00007891
Radiolabeled Monoclonal Antibody Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
A Phase 1 study testing filgrastim, autologous bone marrow transplantation and peripheral blood stem cell transplantation in people with Breast Cancer, run by Cancer Research Institute of Contra Costa 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 or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy… 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, autologous bone marrow transplantation and peripheral blood stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jun 1997to Oct 2004
- 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 confirmed metastatic breast cancer
- BrE-3 positive
- Relapsed or refractory disease with tumor progression after effective therapy allowed
- Measurable or evaluable disease
- Received at least one prior chemotherapy regimen for metastatic disease and have at least one of the following:
- Chemotherapy refractory liver metastases more than 2 cm
- Multiple non-resectable liver metastases
- Brain metastases
- Prior high-dose chemotherapy
- Relapse within prior radiotherapy field
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Over 18
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm3
- Absolute neutrophil count greater than 1,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin less than 2 times normal
- SGOT/SGPT less than 2 times normal
Renal:
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- LVEF greater than 45% by MUGA scan
Pulmonary:
- DLCO and FEV 1.0 greater than 60% predicted
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to E. coli derived proteins
- No other comorbid condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior high-dose chemotherapy with autologous peripheral blood stem cell transplantation
Chemotherapy:
- See Disease Characteristics
- See Biologic therapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Other:
- Recovered from prior therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
Cancer Research Institute of Contra Costa
San Francisco, California, 94107
About this study
Official title: Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With 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 or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90 labeled, humanized monoclonal antibody BrE-3 when given in combination with indium In 111 labeled, humanized monoclonal antibody BrE-3 followed by autologous bone marrow or peripheral blood stem cell transplantation in patients with metastatic breast cancer.
- Determine hematopoietic engraftment in these patients treated with this regimen.
- Determine the ability of indium In 111 labeled, humanized monoclonal antibody BrE-3 to image metastatic disease in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the preliminary antitumor response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of yttrium Y 90 labeled, humanized monoclonal antibody BrE-3 (Y90 huMOAB BrE-3).
Patients receive Y90 huMOAB BrE-3 and indium In 111 labeled, humanized monoclonal antibody BrE-3 IV over 1-2 hours on day -14. Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients also receive filgrastim (G-CSF) IV beginning on day 0 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 huMOAB BrE-3 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 toxicities.
Patients are followed every 3-4 months for 1 year and then at least annually thereafter.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, autologous bone marrow transplantation, peripheral blood stem cell transplantation, indium In 111 monoclonal antibody BrE-3, yttrium Y 90 monoclonal antibody BrE-3
- 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
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
indium In 111 monoclonal antibody BrE-3Radiation
yttrium Y 90 monoclonal antibody BrE-3Radiation
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 startJun 1997
- Study completionOct 2004
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.
- 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
- Cancer Research Institute of Contra Costa
- Sponsor type
- University, hospital or other
- Investigators
- Roberto L. Ceriani, MD, PhD, Study chair, Cancer Research Institute of Contra Costa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007891
- Sponsor's protocol ID
- CRICC-BB-IND-7186
- Other IDs
- CDR0000068340, UCHSC-97467, NCI-V00-1637
- Status last verified
- Sep 2004
- First submitted
- 6 Jan 2001
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00007891
- Acronym / sponsor ID
- CRICC-BB-IND-7186
- 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
- Cancer Research Institute of Contra CostaUniversity, hospital or other
- Study start
- Jun 1997
- Study completion
- Oct 2004 (actual)
- 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 or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90 labeled, humanized monoclonal antibody BrE-3 when given in combination with indium In 111 labeled, humanized monoclonal antibody BrE-3 followed by autologous bone marrow or peripheral blood stem cell transplantation in patients with metastatic breast cancer.
- Determine hematopoietic engraftment in these patients treated with this regimen.
- Determine the ability of indium In 111 labeled, humanized monoclonal antibody BrE-3 to image metastatic disease in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the preliminary antitumor response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of yttrium Y 90 labeled, humanized monoclonal antibody BrE-3 (Y90 huMOAB BrE-3).
Patients receive Y90 huMOAB BrE-3 and indium In 111 labeled, humanized monoclonal antibody BrE-3 IV over 1-2 hours on day -14. Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients also receive filgrastim (G-CSF) IV beginning on day 0 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 huMOAB BrE-3 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 toxicities.
Patients are followed every 3-4 months for 1 year and then at least annually thereafter.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
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 | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| indium In 111 monoclonal antibody BrE-3 | Radiation | – |
| yttrium Y 90 monoclonal antibody BrE-3 | 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 15 May 2013.
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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.
Roberto L. Ceriani, MD, PhD study chair
Cancer Research Institute of Contra Costa
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, autologous bone marrow transplantation and peripheral blood stem cell transplantation in people with Breast Cancer, run by Cancer Research Institute of Contra Costa 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 15 May 2013. 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 15 May 2013.