Breast CancerPhase 2NCT00429507
Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
A Phase 2 study testing 153 Sm-EDTMP, Questionnaire and Stem Cell Transplant in people with Breast Cancer and Bone Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary objectives: To determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT). Secondary objectives: To determine the overall survival at one year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Bone Metastases
- What is being tested?
- 153 Sm-EDTMP, Questionnaire and Stem Cell Transplant
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV breast cancer metastatic to bone and/or bone marrow only.
- Age between 18 and 65 years.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1
- Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.
- Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.
- White blood cell count (WBC) >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.
Show all 11Show fewer
- Adequate pulmonary function defined as forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for hemoglobin) >/= 50% of predicted.
- Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.
- Serum total bilirubin < 2x upper limit of normal (ULN), and ALT/serum glutamate pyruvate transaminase (SGPT) < 3x ULN
- Creatinine clearance of >/= 75 mL/min for subjects up to 50 years of age, and adjusted for age by a 10% decrease per decade for subjects of more than 50 years of age.
- Ability to understand the study and provide informed consent.
Who cannot join
- Any metastatic disease or history of metastatic disease other than skeletal metastases
- Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.
- Previous strontium-89 or samarium-153 treatment for any skeletal involvement.
- Cumulative external beam radiation to > 20% of marrow volume or > 40 Gy to any single region of the spinal cord.
- Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.
- Life expectancy severely limited by concomitant illness (less than 6 months).
Show all 17Show fewer
- Prior nephrectomy.
- History of hemorrhagic cystitis obstructive uropathy or hydronephrosis.
- Uncontrolled arrhythmia or symptomatic cardiac disease.
- Current gross hematuria in urinalysis (UA) in the absence of vaginal bleeding.
- Evidence of HIV-seropositivity.
- Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.
- Use of any investigational agent within 30 days preceding enrollment.
- Pregnant or lactating women.
- Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Myelodysplastic syndrome.
- Subject weight of more than 125 kg.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
Primary objectives:
- To determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).
Secondary objectives:
- To determine the overall survival at one year.
- To determine the efficacy of 153Sm-EDTMP at 6 months.
- To assess pain in subjects treated with 153Sm-EDTMP.
- To determine the safety of 153Sm-EDTMP.
Read the detailed description
153 Sm-EDTMP is designed to provide radiation to the bone and bone marrow. The radiation may kill cancer cells.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a breast exam, mammogram, and computed tomography (CT) scan. You will have a bone marrow aspirate/biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow/bone is withdrawn through a large needle. Blood (about 2 teaspoons) will be drawn to check the status of the disease. You will have x-rays, a bone scan, a positron emissions tomography (PET) scan, and a bone density test. Blood (about 2 teaspoons) will be drawn to check for HIV (the virus that causes AIDS), CMV (cytomegalovirus), Hepatitis B, and Hepatitis C (viruses that can infect the liver). You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have an echocardiogram or multiple-gated acquisition scan (MUGA). An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size. You will have a lung function test to make sure your heart and lungs are healthy. You will complete a questionnaire about the pain you are experiencing. The questionnaire will take about 15 minutes to complete. Women who are able to have children must have a negative blood (about 2 teaspoons) pregnancy test.
If you are found to be eligible to take part in this study, on Day 1 you will receive a tracer dose. A tracer dose is a small amount of the study drug used to measure how the study drug is affecting the body. Your weight will be measured. Before the tracer dose is injected, you will be given fluids through a needle in your veins starting from 2 hours before the tracer dose up to 6 hours afterwards. You will receive a small amount of 153 Sm-EDTMP, called a tracer dose, through a needle in your vein.
After the tracer dose, you will have pictures taken of your body with a gamma camera 3 times that day. These photographs will be taken immediately after the dose is injected, and then 2-3 hours and 4-6 hours later. You will need to lie flat for these imaging sessions for about 10-30 minutes each time.
On Day 2, you will have 1 picture taken of your body with the gamma camera.
If, based on the photographs taken, doctors find that the drug does not go to your bones as expected, you will be removed from the study. If you leave the study at this point, you will have return to the clinic 2 times a week for the next 4 weeks. At these visits you will have a complete physical exam, and you will be asked about any side effects you may be experiencing.
If enough of the study drug does go to your bones, you will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
Before the therapy dose begins, you will have a physical exam, including measurement of your vital signs. Fluids will be given through a needle in your vein beginning 2 hours before the therapy dose and continuing up to 6 hours after.
You will receive the injection of 153 Sm-EDTMP through your central line. The injection will take about 15 minutes. Afterwards, your vital signs will be measured. Blood (about 2 teaspoons) will be drawn for routine tests.
The therapy dose of 153 Sm-EDTMP is expected to destroy your body's ability to make blood cells. To restore your blood-making ability, you will be given back stem cells (blood-forming cells) that will have already been taken from your body and stored for this treatment. This is called an autologous peripheral blood stem cell transplant. You will receive the stem cells given through a needle in your vein 14-21 days after the therapy dose usually as an outpatient procedure.
Family members may not be allowed with you until radiation subsides. This will reduce their exposure to radiation. You will be given instructions on how to follow radiation safety practices.
Once the radiation subsides you will be released from the hospital, at least 2 times a week you will have a complete physical exam, and you will be asked about any side effects you are experiencing. Blood (about 2 teaspoons) will be drawn up to 3 times a week until your stem cell transplant. Your vitals signs will also be checked 2 times a week.
After the transplant, at least 2 times a week for up to two (2) weeks your blood (about 2 teaspoons) will be drawn for routine tests. You will have a physical exam and your vital signs will be checked. You will receive additional care, drugs, or blood transfusions, as needed.
You will return for follow-up visits every 3 months until the end of Year 2 and then every 6 months in Years 3 and 4. Tests may occur more often if a side effect is noticed. Any side effects that you develop will be monitored until it goes away. Some of these exams and tests may take place with your home doctor, and these records will need to be sent to the study doctor so he/she can review them for careful monitoring.
In order to check the response of the cancer to the study therapy, you will have chest x-rays, CT scans, and bone scans every 3 months for the first 2 years after transplant. These will be repeated every 6 months in years 3-4 and once a year after that, as long as your cancer does not get worse. If the breast cancer has spread to your bone marrow at the time you enter this study, bone marrow biopsies will also be done at these times to see whether the cancer is responding. You will also have a PET scan at 6 months after transplant, and more often if your physician believes it will be helpful. Mammograms and bone density exams will be done once a year.
Once a year for the 10 years after you leave the study, you will have a study visit or you will be contacted by telephone. You will be asked about your general health, hospitalization, and cancer treatments.
This is an investigational study. 153 Sm-EDTMP is FDA-approved and commercially available for bone pain control. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer, Bone Metastases
- Being tested
- 153 Sm-EDTMP, Questionnaire, Stem Cell Transplant
- Keywords
- Breast Cancer, Blood Stem Cell, Bone Metastases, Radiation Therapy, Gamma Camera, Sm-EDTMP, Samarium 153-EDTMP, Stem Cell Transplant, Autologous Peripheral Blood Stem Cell Transplantation, PBSCT, Questionnaire
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
153 Sm-EDTMPDrug
Also called Samarium 153-EDTMP
Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking about 15 minutes to complete.
Stem Cell TransplantProcedure or surgery
Also called SCT, Autologous Peripheral Blood Stem Cell Transplantation, PBSCT
Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
| Study group | Role | What they receive |
|---|---|---|
| Samarium 153-EDTMP + Stem Cell Transplant | Experimental | Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete. Receives: Drug: 153 Sm-EDTMP; Behavioral: Questionnaire; Procedure: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Time to progression is measured as the time from study entry to the development of disease progression.
Measured: 7.5 Years, Study period was March 2007 to November 2014.
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 startMar 2007
- Primary completionNov 2014
- Study completionNov 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cytogen Corporation
- Responsible party
- Sponsor
- Investigators
- Naoto Ueno, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429507
- Sponsor's protocol ID
- 2006-0349
- Other IDs
- NCI-2010-00573
- Status last verified
- Oct 2015
- First submitted
- 29 Jan 2007
- Last updated
- 24 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
- ClinicalTrials.gov ID
- NCT00429507
- Acronym / sponsor ID
- 2006-0349
- Conditions
- Breast Cancer, Bone Metastases
- Keywords
- Breast Cancer, Blood Stem Cell, Bone Metastases, Radiation Therapy, Gamma Camera, Sm-EDTMP, Samarium 153-EDTMP, Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cytogen Corporation
- Study start
- Mar 2007
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 31 Jan 2007 (estimated)
- Results
- Posted 24 Nov 2015
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 determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).
Secondary objectives:
- To determine the overall survival at one year.
- To determine the efficacy of 153Sm-EDTMP at 6 months.
- To assess pain in subjects treated with 153Sm-EDTMP.
- To determine the safety of 153Sm-EDTMP.
Detailed description
153 Sm-EDTMP is designed to provide radiation to the bone and bone marrow. The radiation may kill cancer cells.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a breast exam, mammogram, and computed tomography (CT) scan. You will have a bone marrow aspirate/biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow/bone is withdrawn through a large needle. Blood (about 2 teaspoons) will be drawn to check the status of the disease. You will have x-rays, a bone scan, a positron emissions tomography (PET) scan, and a bone density test. Blood (about 2 teaspoons) will be drawn to check for HIV (the virus that causes AIDS), CMV (cytomegalovirus), Hepatitis B, and Hepatitis C (viruses that can infect the liver). You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have an echocardiogram or multiple-gated acquisition scan (MUGA). An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size. You will have a lung function test to make sure your heart and lungs are healthy. You will complete a questionnaire about the pain you are experiencing. The questionnaire will take about 15 minutes to complete. Women who are able to have children must have a negative blood (about 2 teaspoons) pregnancy test.
If you are found to be eligible to take part in this study, on Day 1 you will receive a tracer dose. A tracer dose is a small amount of the study drug used to measure how the study drug is affecting the body. Your weight will be measured. Before the tracer dose is injected, you will be given fluids through a needle in your veins starting from 2 hours before the tracer dose up to 6 hours afterwards. You will receive a small amount of 153 Sm-EDTMP, called a tracer dose, through a needle in your vein.
After the tracer dose, you will have pictures taken of your body with a gamma camera 3 times that day. These photographs will be taken immediately after the dose is injected, and then 2-3 hours and 4-6 hours later. You will need to lie flat for these imaging sessions for about 10-30 minutes each time.
On Day 2, you will have 1 picture taken of your body with the gamma camera.
If, based on the photographs taken, doctors find that the drug does not go to your bones as expected, you will be removed from the study. If you leave the study at this point, you will have return to the clinic 2 times a week for the next 4 weeks. At these visits you will have a complete physical exam, and you will be asked about any side effects you may be experiencing.
If enough of the study drug does go to your bones, you will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
Before the therapy dose begins, you will have a physical exam, including measurement of your vital signs. Fluids will be given through a needle in your vein beginning 2 hours before the therapy dose and continuing up to 6 hours after.
You will receive the injection of 153 Sm-EDTMP through your central line. The injection will take about 15 minutes. Afterwards, your vital signs will be measured. Blood (about 2 teaspoons) will be drawn for routine tests.
The therapy dose of 153 Sm-EDTMP is expected to destroy your body's ability to make blood cells. To restore your blood-making ability, you will be given back stem cells (blood-forming cells) that will have already been taken from your body and stored for this treatment. This is called an autologous peripheral blood stem cell transplant. You will receive the stem cells given through a needle in your vein 14-21 days after the therapy dose usually as an outpatient procedure.
Family members may not be allowed with you until radiation subsides. This will reduce their exposure to radiation. You will be given instructions on how to follow radiation safety practices.
Once the radiation subsides you will be released from the hospital, at least 2 times a week you will have a complete physical exam, and you will be asked about any side effects you are experiencing. Blood (about 2 teaspoons) will be drawn up to 3 times a week until your stem cell transplant. Your vitals signs will also be checked 2 times a week.
After the transplant, at least 2 times a week for up to two (2) weeks your blood (about 2 teaspoons) will be drawn for routine tests. You will have a physical exam and your vital signs will be checked. You will receive additional care, drugs, or blood transfusions, as needed.
You will return for follow-up visits every 3 months until the end of Year 2 and then every 6 months in Years 3 and 4. Tests may occur more often if a side effect is noticed. Any side effects that you develop will be monitored until it goes away. Some of these exams and tests may take place with your home doctor, and these records will need to be sent to the study doctor so he/she can review them for careful monitoring.
In order to check the response of the cancer to the study therapy, you will have chest x-rays, CT scans, and bone scans every 3 months for the first 2 years after transplant. These will be repeated every 6 months in years 3-4 and once a year after that, as long as your cancer does not get worse. If the breast cancer has spread to your bone marrow at the time you enter this study, bone marrow biopsies will also be done at these times to see whether the cancer is responding. You will also have a PET scan at 6 months after transplant, and more often if your physician believes it will be helpful. Mammograms and bone density exams will be done once a year.
Once a year for the 10 years after you leave the study, you will have a study visit or you will be contacted by telephone. You will be asked about your general health, hospitalization, and cancer treatments.
This is an investigational study. 153 Sm-EDTMP is FDA-approved and commercially available for bone pain control. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samarium 153-EDTMP + Stem Cell Transplant | Experimental | Drug: 153 Sm-EDTMP, Behavioral: Questionnaire, Procedure: Stem Cell TransplantSamarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Stage IV breast cancer metastatic to bone and/or bone marrow only.
- Age between 18 and 65 years.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1
- Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.
- Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.
Key exclusion criteria (17 listed)
- Any metastatic disease or history of metastatic disease other than skeletal metastases
- Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.
- Previous strontium-89 or samarium-153 treatment for any skeletal involvement.
- Cumulative external beam radiation to > 20% of marrow volume or > 40 Gy to any single region of the spinal cord.
- Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.
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 |
|---|---|---|
| 153 Sm-EDTMPAlso: Samarium 153-EDTMPTracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. | Drug | Samarium 153-EDTMP + Stem Cell Transplant |
| QuestionnaireAlso: SurveyQuestionnaires taking about 15 minutes to complete. | Behavioural | Samarium 153-EDTMP + Stem Cell Transplant |
| Stem Cell TransplantAlso: SCT, Autologous Peripheral Blood Stem Cell Transplantation, PBSCTStem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. | Procedure or surgery | Samarium 153-EDTMP + Stem Cell Transplant |
Primary outcome
Time to Progression
Time frame: 7.5 Years, Study period was March 2007 to November 2014.
Time to progression is measured as the time from study entry to the development of disease progression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink 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 153 Sm-EDTMP, Questionnaire and Stem Cell Transplant in people with Breast Cancer and Bone Metastases, 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 11 inclusion and 17 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 24 Nov 2015. 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 24 Nov 2015). 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?
Time to Progression (time frame: 7.5 Years, Study period was March 2007 to November 2014.). 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 24 Nov 2015.