Breast CancerPhase 1/2NCT00003086
Repeated Bone Marrow Transplantation in Treating Women With Advanced Breast Cancer
A Phase 1/2 study testing filgrastim, CAF regimen and carboplatin in people with Breast Cancer, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, CAF regimen and carboplatin
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to 28 Jan 2001
- Phase
- Phase 1/2
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer Adequate peripheral blood stem cells harvested and stored
PATIENT CHARACTERISTICS: Age: 21-65 Sex: Female Performance status: 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection fraction of at least 50% No symptomatic coronary artery disease Pulmonary: FEV1 and DLCO greater than 50% of predicted Other: Not pregnant Not HIV positive Not hepatitis B surface antigen positive No uncontrolled infection No other prior malignancy within 5 years except: Curatively treated in situ adenocarcinoma of the cervix Curatively treated nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior therapy Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for metastatic disease Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University School of Medicine
Shreveport, Louisiana, 71130-3932
About this study
Official title: Phase I/II Study of Samarium 153 as Part of a Double (Sequential) Autologous Bone Marrow Transplant (ABMT) for Patients With Stage IV Breast Cancer
RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of samarium 153 used sequentially with autologous bone marrow transplantation for metastatic breast cancer. II. Determine the response rate, median duration of response, and overall survival of patients who respond to induction therapy followed by 2 cycles of high dose chemotherapy and stem cell support.
OUTLINE: This is a dose escalation study. Patients are first treated with salvage chemotherapy for no more than 4 cycles. At least a partial remission must be achieved. Peripheral blood stem cells (PBSC) are collected following the administration of filgrastim (granulocyte colony-stimulating factor; G-CSF). After recovery from the prior chemotherapy, high dose chemotherapy begins. Paclitaxel is administered as a 24 hour infusion on day -7. Melphalan IV is administered over 1 hour on days -6 and -5. PBSC are infused on day 0. A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy. Samarium 153 is administered on day -14. Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached (defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients). Cyclophosphamide, thiotepa, and carboplatin are infused over 24 hours on days -7 through -4. PBSC are infused on day 0 followed by G-CSF IV. The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study. Patients are followed until death.
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, CAF regimen, carboplatin, cisplatin, cyclophosphamide
- Keywords
- stage IV 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
CAF regimenDrug
carboplatinDrug
cisplatinDrug
cyclophosphamideDrug
fluorouracilDrug
ifosfamideDrug
melphalanDrug
paclitaxelDrug
thiotepaDrug
peripheral blood stem cell transplantationProcedure or surgery
samarium Sm 153 lexidronam pentasodiumRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2004 (estimated)
- Study startMar 1997
- Primary completion28 Jan 2001
- Study completion28 Jan 2001
Why it stopped: no participants enrolled in a three year period
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 1/2
- Primary purpose
- Treatment
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin B. Weinberger, MD, Study chair, Feist-Weiller Cancer Center at Louisiana State University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003086
- Sponsor's protocol ID
- LSU-97447
- Other IDs
- CDR0000065786, NCI-V97-1341
- Status last verified
- Jul 2020
- First submitted
- 1 Nov 1999
- Last updated
- 14 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Samarium 153 as Part of a Double (Sequential) Autologous Bone Marrow Transplant (ABMT) for Patients With Stage IV Breast Cancer
- ClinicalTrials.gov ID
- NCT00003086
- Acronym / sponsor ID
- LSU-97447
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no participants enrolled in a three year period
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Mar 1997
- Primary completion
- 28 Jan 2001 (actual)
- Study completion
- 28 Jan 2001 (actual)
- First posted
- 9 Feb 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: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast cancer.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of samarium 153 used sequentially with autologous bone marrow transplantation for metastatic breast cancer. II. Determine the response rate, median duration of response, and overall survival of patients who respond to induction therapy followed by 2 cycles of high dose chemotherapy and stem cell support.
OUTLINE: This is a dose escalation study. Patients are first treated with salvage chemotherapy for no more than 4 cycles. At least a partial remission must be achieved. Peripheral blood stem cells (PBSC) are collected following the administration of filgrastim (granulocyte colony-stimulating factor; G-CSF). After recovery from the prior chemotherapy, high dose chemotherapy begins. Paclitaxel is administered as a 24 hour infusion on day -7. Melphalan IV is administered over 1 hour on days -6 and -5. PBSC are infused on day 0. A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy. Samarium 153 is administered on day -14. Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached (defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients). Cyclophosphamide, thiotepa, and carboplatin are infused over 24 hours on days -7 through -4. PBSC are infused on day 0 followed by G-CSF IV. The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study. Patients are followed until death.
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- 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 | – |
| CAF regimen | Drug | – |
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| fluorouracil | Drug | – |
| ifosfamide | Drug | – |
| melphalan | Drug | – |
| paclitaxel | Drug | – |
| thiotepa | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| samarium Sm 153 lexidronam pentasodium | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: no participants enrolled in a three year period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
Benjamin B. Weinberger, MD study chair
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing filgrastim, CAF regimen and carboplatin in people with Breast Cancer, run by Louisiana State University Health Sciences Center Shreveport 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: stopped early, as of the sponsor's last update on 14 Jul 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: no participants enrolled in a three year period). 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 14 Jul 2020.