Breast CancerPhase 1NCT00003920
Monoclonal Antibody Therapy Plus Cyclosporine and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
A Phase 1 study testing filgrastim, cyclosporine and peripheral blood stem cell transplantation in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, cyclosporine and peripheral blood stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS: Histologically confirmed refractory metastatic breast cancer Must have either relapsed or failed to achieve complete remission after combination chemotherapy with or without stem cell or marrow transplantation No CNS disease No generalized or total mass liver involvement greater than 25% volume No pulmonary metastasis involving greater than 25% of lung volume Tumor markers and evidence of metastatic disease by physical exam or radiography required for patients with bone disease only Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to physiologic age of 55 Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2000/mm3 Platelet count at least 150,000/mm3 Arterial blood gases within normal limits for age and sex Hepatic: See Disease Characteristics Bilirubin no greater than 1.3 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF at least 50% by MUGA Pulmonary: FEV1 and FVC at least 65% of predicted Corrected diffusing capacity at least 60% Other: Adequate venous access Able to tolerate apheresis, filgrastim (G-CSF), and cyclosporine Human anti-mouse antibody (HAMA) negative No other primary malignant neoplasm except curatively treated basal cell carcinoma or surgically cured carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No concurrent chemotherapy At least 1 year since prior high dose intensive marrow toxic therapy requiring stem cells or bone marrow transplantation No pulmonary toxicity due to prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy No prior radiotherapy to greater than 25% of total skeleton Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Pharmacokinetic/Dosimetry/MTNTD Study of 111In/90Y-2IT-BAD-m170 for Therapy in Metastatic Breast Cancer Patients With Post Therapy Support of Autologous Pretherapy Apheresed Peripheral Blood Stem Cells and Cyclosporin A Given for Suppression of HAMA Response
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine may prevent this from happening.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus cyclosporine and peripheral stem cell transplantation in treating patients who have metastatic breast cancer that has not responded to previous therapy.
Read the detailed description
OBJECTIVES: I. Determine variation in indium In 111 labeled 2IT-BAD monoclonal antibody 170 (111In-2IT-BAD-m170) pharmacokinetics before and with each therapy in patients with metastatic breast cancer. II. Determine each therapeutic dose of yttrium Y 90 labeled 2IT-BAD monoclonal antibody 170 (90Y-2IT-BAD-m170) based on the calculated radiation dosimetry for normal nonmarrow tissues from the pharmacokinetic study with 111In-2IT-BAD-m170 performed prior to each therapy course in these patients. III. Determine the maximum tolerated, nonmarrow, normal tissue dose (MTNTD) of 90Y-2IT-BAD-m170 for these patients when up to 3 courses with cyclosporine plus autologous peripheral stem cell support are given every 3 months. IV. Evaluate the safety of and tumor response to 111In/90Y-2IT-BAD-m170 therapy with cyclosporine and autologous peripheral stem cells at the MTNTD in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90 labeled 2IT-BAD monoclonal antibody 170 (90Y-2IT-BAD-m170). Patients are stratified according to risk based on prior therapy (standard combined chemotherapy vs standard and high dose combined chemotherapy with bone marrow transplant or stem cell support). All patients receive subcutaneous filgrastim (G-CSF) during stem cell collection. Beginning 3 to 5 days after starting G-CSF, patients undergo apheresis either daily or every other day for 4 to 8 procedures. Patients receive oral cyclosporine twice daily, starting on day 1, for up to 2 weeks. On day 4, patients receive nonlabeled 2IT-BAD monoclonal antibody m170 IV over 10-15 minutes, followed 15 minutes later by indium In 111 labeled 2IT-BAD monoclonal antibody 170 (111In-2IT-BAD-m170) IV over 10-15 minutes. Patients then undergo dosimetry imaging immediately, again 3 hours later, and then on days 1-4 and day 7 postinjection. Patients receive nonlabeled monoclonal antibody IV over 10-15 minutes, followed 15 minutes later by In 111/Y 90 labeled 2IT-BAD monoclonal antibody 170 (111In/90Y-2IT-BAD-m170) IV over 10-15 minutes, then undergo imaging as in pretherapy. Patients also receive cyclosporine, administered as in pretherapy, for a total of 35 days, plus autologous stem cell support followed by G-CSF after each course. Cohorts of 3-9 patients receive escalating doses of 111In/90Y-2IT-BAD-m170. Patients proceed to the next dose level if 3 or more patients in the same or higher risk group have not reached the maximum tolerated, nonmarrow, normal tissue dose (MTNTD) at least 3 months after the second course of therapy. Therapy repeats every 3 months for 3 courses.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, cyclosporine, peripheral blood stem cell transplantation, indium In 111 monoclonal antibody m170, yttrium Y 90 monoclonal antibody m170
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
cyclosporineDrug
peripheral blood stem cell transplantationProcedure or surgery
indium In 111 monoclonal antibody m170Radiation
yttrium Y 90 monoclonal antibody m170Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2004 (estimated)
- Study startApr 1996
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 University of California, DavisThe 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
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Sally DeNardo, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003920
- Sponsor's protocol ID
- UCD-986545
- Other IDs
- CDR0000067105, NCI-V99-1549
- Status last verified
- Nov 2000
- First submitted
- 1 Nov 1999
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Dosimetry/MTNTD Study of 111In/90Y-2IT-BAD-m170 for Therapy in Metastatic Breast Cancer Patients With Post Therapy Support of Autologous Pretherapy Apheresed Peripheral Blood Stem Cells and Cyclosporin A Given for Suppression of HAMA Response
- ClinicalTrials.gov ID
- NCT00003920
- Acronym / sponsor ID
- UCD-986545
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 1996
- First posted
- 17 Jun 2004 (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 deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine may prevent this from happening.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus cyclosporine and peripheral stem cell transplantation in treating patients who have metastatic breast cancer that has not responded to previous therapy.
Detailed description
OBJECTIVES: I. Determine variation in indium In 111 labeled 2IT-BAD monoclonal antibody 170 (111In-2IT-BAD-m170) pharmacokinetics before and with each therapy in patients with metastatic breast cancer. II. Determine each therapeutic dose of yttrium Y 90 labeled 2IT-BAD monoclonal antibody 170 (90Y-2IT-BAD-m170) based on the calculated radiation dosimetry for normal nonmarrow tissues from the pharmacokinetic study with 111In-2IT-BAD-m170 performed prior to each therapy course in these patients. III. Determine the maximum tolerated, nonmarrow, normal tissue dose (MTNTD) of 90Y-2IT-BAD-m170 for these patients when up to 3 courses with cyclosporine plus autologous peripheral stem cell support are given every 3 months. IV. Evaluate the safety of and tumor response to 111In/90Y-2IT-BAD-m170 therapy with cyclosporine and autologous peripheral stem cells at the MTNTD in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90 labeled 2IT-BAD monoclonal antibody 170 (90Y-2IT-BAD-m170). Patients are stratified according to risk based on prior therapy (standard combined chemotherapy vs standard and high dose combined chemotherapy with bone marrow transplant or stem cell support). All patients receive subcutaneous filgrastim (G-CSF) during stem cell collection. Beginning 3 to 5 days after starting G-CSF, patients undergo apheresis either daily or every other day for 4 to 8 procedures. Patients receive oral cyclosporine twice daily, starting on day 1, for up to 2 weeks. On day 4, patients receive nonlabeled 2IT-BAD monoclonal antibody m170 IV over 10-15 minutes, followed 15 minutes later by indium In 111 labeled 2IT-BAD monoclonal antibody 170 (111In-2IT-BAD-m170) IV over 10-15 minutes. Patients then undergo dosimetry imaging immediately, again 3 hours later, and then on days 1-4 and day 7 postinjection. Patients receive nonlabeled monoclonal antibody IV over 10-15 minutes, followed 15 minutes later by In 111/Y 90 labeled 2IT-BAD monoclonal antibody 170 (111In/90Y-2IT-BAD-m170) IV over 10-15 minutes, then undergo imaging as in pretherapy. Patients also receive cyclosporine, administered as in pretherapy, for a total of 35 days, plus autologous stem cell support followed by G-CSF after each course. Cohorts of 3-9 patients receive escalating doses of 111In/90Y-2IT-BAD-m170. Patients proceed to the next dose level if 3 or more patients in the same or higher risk group have not reached the maximum tolerated, nonmarrow, normal tissue dose (MTNTD) at least 3 months after the second course of therapy. Therapy repeats every 3 months for 3 courses.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 | – |
| cyclosporine | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| indium In 111 monoclonal antibody m170 | Radiation | – |
| yttrium Y 90 monoclonal antibody m170 | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.
Sally DeNardo, MD study chair
University of California, Davis
1 site 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, cyclosporine and peripheral blood stem cell transplantation in people with Breast Cancer, run by University of California, Davis at 1 site 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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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 7 Aug 2013.