Breast CancerPhase 2NCT00429572
Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer
A Phase 2 study testing Fludarabine, Melphalan and Stem Cell Infusion in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer. 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fludarabine, Melphalan and Stem Cell Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recurrent or residual metastatic breast carcinoma
- Zubrod performance status less than 2
- 18-60 years old
- Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.
- No major organ dysfunction or active infection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Primary Objectives:
- To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer.
- To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progression free survival (PFS) rate.
- To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.
Read the detailed description
If tumors shrink by standard-dose chemotherapy, patients will receive moderate dose chemotherapy to prepare for the blood stem cell transplant. The drug fludarabine will be given by vein on days 1-5. The drug melphalan will be given by vein on days 4 and 5. Day 6 will be a rest day; no drugs will be given. The blood stem cell transplant will be given on day 7. Bone marrow from the matched donor may be used instead of blood stem cells, particularly for unrelated donors. A catheter (tube) will be placed in a large vein in the chest to reduce the number of times patients are stuck with a needle.
Researchers will collect blood stem cells from your brother or sister or from an unrelated donor using granulocyte colony-stimulating factor (G-CSF) before receiving high-dose chemotherapy. You will need to have enough stem cells before transplantation.
The drugs G-CSG, tacrolimus, and methotrexate will be given to ease side effects and help blood counts return to normal after the transplant. G-CSF is given as a shot under the skin, starting the day from transplant and continuing until the white blood cell count is normal. Tacrolimus is given by vein or by mouth for 4 to 7 months; during the last month it is given, the dose will be tapered off. Methotrexate is given by vein on days 1, 3, and 6 after transplant. Day 11 of methotrexate is given additionally if a donor is unrelated. Blood transfusions may be needed also.
Antithymocyte globulin will be given to patients who receive blood or bone marrow from donors whose cells do exactly match the patients or from unrelated donors.
Sometimes the transplanted cells attack the normal cells in the patient's body instead of the cancer cells. This is called graft-vs-host disease (GVHD). The drug methylprednisolone will be given by vein or by mouth to fight GVHD is it occurs.
Patients must stay in the hospital for about 3 to 4 weeks. Patients must stay in the Houston area for about 100 days after the transplant. Blood tests will be done daily while the patient is in the hospital. Blood and urine tests and chest x-rays, computer tomography (CT) scans, and/or bone scans will be done during the 100 days.
If there are no signs of disease after 100 days, treatment will stop. Patients must return to the clinic for check-ups once a month for the first year, 3 times a year for 4 years, and once a year after that. If disease is till present after 100 days, but the patient does not have GVHD, the patient may receive an infusion of donor lymphocytes by vein. This treatment may be repeated up to 3 times with 8 weeks between infusions. If no disease is found or if GVHD occurs, treatment will stop.
Before treatment starts, patients will have a complete exam including blood and urine tests. An EKG (heart function test) and a heart scan will be done. Patients will have a dental exam. A test of lung function will be done. A sample of breast tissue will be taken. This is done with a hollow needle while the doctor looks at a CT scan or with a lighted tube placed through a cut in the breast while the patient is under anesthesia.
Herceptin will be given every week, if you have Human Epidermal growth factor Receptor 2 (HER-2)/neu-overexpressing tumor. Prior to this an infusion heart test will be done.
This is an investigational study. Docetaxel, Melphalan, and Herceptin are approved by the US Food and Drug Administration for use against breast cancer. About 40 patients will take part in the study.
- Conditions
- Breast Cancer
- Being tested
- Fludarabine, Melphalan, Stem Cell Infusion
- Keywords
- Breast Cancer, PBPC Transplantation, Stem Cell Infusion, Fludarabine, Melphalan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
30 mg/m^2 intravenously Daily for 5 Days
MelphalanDrug
70 mg/m^2 intravenously Daily for 2 Days
Stem Cell InfusionProcedure or surgery
Also called mini-allogeneic PBPC transplantation, Stem Cell Transplant, SCT
Stem Cell Infusion on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Transplantation | Experimental | Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7. Receives: Drug: Fludarabine; Drug: Melphalan; Procedure: Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tumor Response
Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.
Measured: Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.
Overall Survival
Survival duration was calculated from time of transplantation by number of days.
Measured: Transplant until death.
Time to Progressive Disease
Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first.
Measured: Transplant to Progression.
Grade II-IV Toxicity
Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe).
Measured: Up to one year.
Number of Participants With Acute or Chronic GVHD And Response to Therapy
Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from "Consensus conference on acute GVHD grading," Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy.
Measured: Transplant to 1 year post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 1998
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naoto Ueno, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429572
- Sponsor's protocol ID
- DM97-268
- Status last verified
- Aug 2012
- First submitted
- 29 Jan 2007
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00429572
- Acronym / sponsor ID
- DM97-268
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, PBPC Transplantation, Stem Cell Infusion, Fludarabine, Melphalan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 31 Jan 2007 (estimated)
- Results
- Posted 13 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer.
- To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progression free survival (PFS) rate.
- To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.
Detailed description
If tumors shrink by standard-dose chemotherapy, patients will receive moderate dose chemotherapy to prepare for the blood stem cell transplant. The drug fludarabine will be given by vein on days 1-5. The drug melphalan will be given by vein on days 4 and 5. Day 6 will be a rest day; no drugs will be given. The blood stem cell transplant will be given on day 7. Bone marrow from the matched donor may be used instead of blood stem cells, particularly for unrelated donors. A catheter (tube) will be placed in a large vein in the chest to reduce the number of times patients are stuck with a needle.
Researchers will collect blood stem cells from your brother or sister or from an unrelated donor using granulocyte colony-stimulating factor (G-CSF) before receiving high-dose chemotherapy. You will need to have enough stem cells before transplantation.
The drugs G-CSG, tacrolimus, and methotrexate will be given to ease side effects and help blood counts return to normal after the transplant. G-CSF is given as a shot under the skin, starting the day from transplant and continuing until the white blood cell count is normal. Tacrolimus is given by vein or by mouth for 4 to 7 months; during the last month it is given, the dose will be tapered off. Methotrexate is given by vein on days 1, 3, and 6 after transplant. Day 11 of methotrexate is given additionally if a donor is unrelated. Blood transfusions may be needed also.
Antithymocyte globulin will be given to patients who receive blood or bone marrow from donors whose cells do exactly match the patients or from unrelated donors.
Sometimes the transplanted cells attack the normal cells in the patient's body instead of the cancer cells. This is called graft-vs-host disease (GVHD). The drug methylprednisolone will be given by vein or by mouth to fight GVHD is it occurs.
Patients must stay in the hospital for about 3 to 4 weeks. Patients must stay in the Houston area for about 100 days after the transplant. Blood tests will be done daily while the patient is in the hospital. Blood and urine tests and chest x-rays, computer tomography (CT) scans, and/or bone scans will be done during the 100 days.
If there are no signs of disease after 100 days, treatment will stop. Patients must return to the clinic for check-ups once a month for the first year, 3 times a year for 4 years, and once a year after that. If disease is till present after 100 days, but the patient does not have GVHD, the patient may receive an infusion of donor lymphocytes by vein. This treatment may be repeated up to 3 times with 8 weeks between infusions. If no disease is found or if GVHD occurs, treatment will stop.
Before treatment starts, patients will have a complete exam including blood and urine tests. An EKG (heart function test) and a heart scan will be done. Patients will have a dental exam. A test of lung function will be done. A sample of breast tissue will be taken. This is done with a hollow needle while the doctor looks at a CT scan or with a lighted tube placed through a cut in the breast while the patient is under anesthesia.
Herceptin will be given every week, if you have Human Epidermal growth factor Receptor 2 (HER-2)/neu-overexpressing tumor. Prior to this an infusion heart test will be done.
This is an investigational study. Docetaxel, Melphalan, and Herceptin are approved by the US Food and Drug Administration for use against breast cancer. About 40 patients will take part in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Transplantation | Experimental | Drug: Fludarabine, Drug: Melphalan, Procedure: Stem Cell InfusionIntravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Recurrent or residual metastatic breast carcinoma
- Zubrod performance status less than 2
- 18-60 years old
- Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.
- No major organ dysfunction or active infection
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fludarabine30 mg/m^2 intravenously Daily for 5 Days | Drug | Allogeneic Transplantation |
| Melphalan70 mg/m^2 intravenously Daily for 2 Days | Drug | Allogeneic Transplantation |
| Stem Cell InfusionAlso: mini-allogeneic PBPC transplantation, Stem Cell Transplant, SCTStem Cell Infusion on Day 0. | Procedure or surgery | Allogeneic Transplantation |
Primary outcome
Number of Participants With Tumor Response
Time frame: Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.
Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.
Overall Survival
Time frame: Transplant until death.
Survival duration was calculated from time of transplantation by number of days.
Time to Progressive Disease
Time frame: Transplant to Progression.
Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first.
Grade II-IV Toxicity
Time frame: Up to one year.
Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe).
Number of Participants With Acute or Chronic GVHD And Response to Therapy
Time frame: Transplant to 1 year post transplant
Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from "Consensus conference on acute GVHD grading," Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
Naoto Ueno, MD, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Melphalan and Stem Cell Infusion in people with Breast Cancer, run by M.D. Anderson Cancer Center 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?
The sponsor lists 5 inclusion and 0 exclusion criteria. 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 7 Aug 2012. 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 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?
Yes. Results are posted in the registry (first posted 13 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Participants With Tumor Response (time frame: Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 2012.