Melanoma (Skin)Phase 2NCT00096382
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma
A Phase 2 study testing aldesleukin, filgrastim and therapeutic tumor infiltrating lymphocytes in people with Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- aldesleukin, filgrastim and therapeutic tumor infiltrating lymphocytes
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic melanoma
- Measurable disease
- Resected or stable brain metastases are allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-1
Life expectancy
- At least 3 months
Hematopoietic
- See Immunologic
- Absolute neutrophil count > 1,000/mm^3 (without support of filgrastim [G-CSF])
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- No coagulation disorders
Hepatic
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 times upper limit of normal
- Bilirubin ≤ 2 mg/dL (< 3 mg/dL in patients with Gilbert's syndrome)
- No hepatitis B or C
Renal
- Creatinine ≤ 1.6 mg/dL
Cardiovascular
- Left ventricular ejection fraction (LVEF) ≥ 45% by cardiac stress test*
- No active major cardiovascular illness as evidenced by stress thallium or other comparable test
- No myocardial infarction
- No cardiac arrhythmias NOTE: *For patients ≥ 50 years of age receiving high-dose interleukin-2 (IL-2) OR patients with a history of electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia, or arrhythmias
Pulmonary
- Forced expiratory volume 1 (FEV_1) ≥ 60% of predicted by pulmonary function test in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction*
- No active major respiratory illness
- No obstructive or restrictive pulmonary disease NOTE: *For patients receiving high-dose IL-2 only
Immunologic
- No active major immunologic illness
- No active systemic infections
- No primary or secondary immunodeficiency
- Fully recovered immune competence after prior chemotherapy or radiotherapy as evidenced by both of the following:
- Absolute neutrophil count > 1,000/mm^3
- No opportunistic infections
- Human Immunodeficiency virus (HIV) negative
- Epstein-Barr virus positive
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- At least 6 weeks since prior nitrosourea therapy
- No prior cyclophosphamide and fludarabine as part of a preparative regimen on National Cancer Institute (NCI) Surgery Branch adoptive cell therapy studies unless sufficient numbers of CD34+ stem cells (more than 2 x10^6/kg patient weight) have been obtained prior to the administration of chemotherapy
Endocrine therapy
- No concurrent systemic steroid therapy
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- Prior minor surgery within the past 3 weeks allowed if recovered
Other
- Recovered from all prior therapy
- At least 30 days since prior systemic therapy
- No other concurrent experimental agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
NCI - Surgery Branch
Bethesda, Maryland, 20892-1201
About this study
Official title: Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy, Total Body Irradiation and Reconstitution With CD34+ Cells
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine complete clinical tumor regression in patients with metastatic melanoma treated with a myeloablative lymphoid-depleting preparative regimen comprising cyclophosphamide, fludarabine, and total body irradiation followed by autologous tumor-reactive tumor-infiltrating lymphocyte infusion, autologous CD34+ stem cell transplantation, and low-dose or high-dose interleukin-2.
- Evaluate the safety of this regimen in these patients.
Secondary
- Determine the survival of the infused lymphocytes by analyzing the sequence of the variable region of the T-cell receptor or flow cytometry in patients treated with this regimen.
OUTLINE:
- Autologous stem cell collection: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily for 8 days. Beginning on day 5 of G-CSF, patients undergo apheresis daily for up to 3 days. Patients may receive 1 additional course of G-CSF and apheresis or use stem cells stored from a prior stem cell harvest in order to obtain an adequate number of cells.
- Lymphocyte-depleting myeloablative preparative regimen: Patients receive cyclophosphamide intravenous (IV) over 1 hour on days -5 and -6 and fludarabine IV over 15-30 minutes on days -6 to -2. Patients also undergo total body irradiation on day -1.
- Autologous lymphocyte infusion: Patients receive autologous tumor-reactive tumor-infiltrating lymphocytes IV over 20-30 minutes on day 0* followed by G-CSF SC once daily until blood counts recover.
- Autologous stem cell transplantation: Patients receive autologous CD34+ stem cells IV on day 2.
- Interleukin therapy: Patients are assigned to 1 of 2 cohorts, depending on whether they have received prior high-dose interleukin-2 (IL-2).
- Cohort 1 (patients who received prior high-dose IL-2): Beginning on day 0*, patients receive high-dose IL-2 IV over 15 minutes 3 times daily for up to 5 days (maximum of 15 doses).
- Cohort 3 (patients who have not received prior high-dose IL-2): Patients receive treatment as in cohort 1.
NOTE: *Day 0 is 1-4 days after the last dose of fludarabine.
Patients are evaluated at 4-6 weeks.
PROJECTED ACCRUAL: A total of 116 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- aldesleukin, filgrastim, therapeutic tumor infiltrating lymphocytes, cyclophosphamide, fludarabine phosphate
- Keywords
- stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Also called IL-2, Interleukin-2
high dose: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days (maximum 5 doses) or low dose: 250,000 IU/kg subcutaneously daily for 5 days, after a two day rest, 125,000 IU/kg subcutaneously daily for 5 days for five weeks (2 days rest per week)
filgrastimBiological
Also called GCSF
10 mcg/kg/day daily subcutaneously until neutrophil count >1x10^9/1.
therapeutic tumor infiltrating lymphocytesBiological
Lymphocytes that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
cyclophosphamideDrug
Also called Cytoxan
60 mg/kg/day x 2 days intravenously over 1 hour
Also called Fludara
25 mg/m^2/day intravenous piggyback daily over 15-20 minutes for 5 days
radiation therapyRadiation
Also called total body irradiation
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
| Study group | Role | What they receive |
|---|---|---|
| TBI 200cGy + TIL +HD IL-2, prior IL-2 | Other | Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient. Receives: Biological: aldesleukin; Biological: filgrastim; Biological: therapeutic tumor infiltrating lymphocytes; Drug: cyclophosphamide; Drug: fludarabine phosphate; Radiation: radiation therapy |
| TBI 200cGy + TIL +HD IL-2, No prior IL-2 | Other | Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient. Receives: Biological: aldesleukin; Biological: filgrastim; Biological: therapeutic tumor infiltrating lymphocytes; Drug: cyclophosphamide; Drug: fludarabine phosphate; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Tumor Regression
Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Measured: Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.
Safety
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startSep 2004
- Primary completionJan 2009
- Study completionJan 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Steven A. Rosenberg, MD, PhD, Principal investigator, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096382
- Sponsor's protocol ID
- 040288
- Other IDs
- 04-C-0288, NCI-7025, NCI-PRMC-P6273, CDR0000393480
- Status last verified
- Sep 2015
- First submitted
- 9 Nov 2004
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yao X, Ahmadzadeh M, Lu YC, Liewehr DJ, Dudley ME, Liu F, Schrump DS, Steinberg SM, Rosenberg SA, Robbins PF. Levels of peripheral CD4(+)FoxP3(+) regulatory T cells are negatively associated with clinical response to adoptive immunotherapy of human cancer. Blood. 2012 Jun 14;119(24):5688-96. doi: 10.1182/blood-2011-10-386482. Epub 2012 May 3.
PubMed 22555974
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy, Total Body Irradiation and Reconstitution With CD34+ Cells
- ClinicalTrials.gov ID
- NCT00096382
- Acronym / sponsor ID
- 040288
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Posted 27 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine complete clinical tumor regression in patients with metastatic melanoma treated with a myeloablative lymphoid-depleting preparative regimen comprising cyclophosphamide, fludarabine, and total body irradiation followed by autologous tumor-reactive tumor-infiltrating lymphocyte infusion, autologous CD34+ stem cell transplantation, and low-dose or high-dose interleukin-2.
- Evaluate the safety of this regimen in these patients.
Secondary
- Determine the survival of the infused lymphocytes by analyzing the sequence of the variable region of the T-cell receptor or flow cytometry in patients treated with this regimen.
OUTLINE:
- Autologous stem cell collection: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily for 8 days. Beginning on day 5 of G-CSF, patients undergo apheresis daily for up to 3 days. Patients may receive 1 additional course of G-CSF and apheresis or use stem cells stored from a prior stem cell harvest in order to obtain an adequate number of cells.
- Lymphocyte-depleting myeloablative preparative regimen: Patients receive cyclophosphamide intravenous (IV) over 1 hour on days -5 and -6 and fludarabine IV over 15-30 minutes on days -6 to -2. Patients also undergo total body irradiation on day -1.
- Autologous lymphocyte infusion: Patients receive autologous tumor-reactive tumor-infiltrating lymphocytes IV over 20-30 minutes on day 0* followed by G-CSF SC once daily until blood counts recover.
- Autologous stem cell transplantation: Patients receive autologous CD34+ stem cells IV on day 2.
- Interleukin therapy: Patients are assigned to 1 of 2 cohorts, depending on whether they have received prior high-dose interleukin-2 (IL-2).
- Cohort 1 (patients who received prior high-dose IL-2): Beginning on day 0*, patients receive high-dose IL-2 IV over 15 minutes 3 times daily for up to 5 days (maximum of 15 doses).
- Cohort 3 (patients who have not received prior high-dose IL-2): Patients receive treatment as in cohort 1.
NOTE: *Day 0 is 1-4 days after the last dose of fludarabine.
Patients are evaluated at 4-6 weeks.
PROJECTED ACCRUAL: A total of 116 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI 200cGy + TIL +HD IL-2, prior IL-2 | Other | Biological: aldesleukin, Biological: filgrastim, Biological: therapeutic tumor infiltrating lymphocytes, Drug: cyclophosphamide, Drug: fludarabine phosphate, Radiation: radiation therapyPatients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient. |
| TBI 200cGy + TIL +HD IL-2, No prior IL-2 | Other | Biological: aldesleukin, Biological: filgrastim, Biological: therapeutic tumor infiltrating lymphocytes, Drug: cyclophosphamide, Drug: fludarabine phosphate, Radiation: radiation therapyPatients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient. |
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 |
|---|---|---|
| aldesleukinAlso: IL-2, Interleukin-2high dose: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days (maximum 5 doses) or low dose: 250,000 IU/kg subcutaneously daily for 5 days, after a two day rest, 125,000 IU/kg subcutaneously daily for 5 days for five weeks (2 days rest per week) | Biological | TBI 200cGy + TIL +HD IL-2, No prior IL-2, TBI 200cGy + TIL +HD IL-2, prior IL-2 |
| filgrastimAlso: GCSF10 mcg/kg/day daily subcutaneously until neutrophil count >1x10^9/1. | Biological | TBI 200cGy + TIL +HD IL-2, No prior IL-2, TBI 200cGy + TIL +HD IL-2, prior IL-2 |
| therapeutic tumor infiltrating lymphocytesLymphocytes that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient. | Biological | TBI 200cGy + TIL +HD IL-2, No prior IL-2, TBI 200cGy + TIL +HD IL-2, prior IL-2 |
| cyclophosphamideAlso: Cytoxan60 mg/kg/day x 2 days intravenously over 1 hour | Drug | TBI 200cGy + TIL +HD IL-2, No prior IL-2, TBI 200cGy + TIL +HD IL-2, prior IL-2 |
| fludarabine phosphateAlso: Fludara25 mg/m^2/day intravenous piggyback daily over 15-20 minutes for 5 days | Drug | TBI 200cGy + TIL +HD IL-2, No prior IL-2, TBI 200cGy + TIL +HD IL-2, prior IL-2 |
| radiation therapyAlso: total body irradiationPatients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. | Radiation | TBI 200cGy + TIL +HD IL-2, No prior IL-2, TBI 200cGy + TIL +HD IL-2, prior IL-2 |
Primary outcome
Clinical Tumor Regression
Time frame: Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.
Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Safety
Time frame: 4 years
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22555974Yao X, Ahmadzadeh M, Lu YC, Liewehr DJ, Dudley ME, Liu F, Schrump DS, Steinberg SM, Rosenberg SA, Robbins PF. Levels of peripheral CD4(+)FoxP3(+) regulatory T cells are negatively associated with clinical response to adoptive immunotherapy of human cancer. Blood. 2012 Jun 14;119(24):5688-96. doi: 10.1182/blood-2011-10-386482. Epub 2012 May 3.
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Steven A. Rosenberg, MD, PhD principal investigator
NCI - Surgery Branch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin, filgrastim and therapeutic tumor infiltrating lymphocytes in people with Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) 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 28 Oct 2015. 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 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 27 Mar 2013). 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?
Clinical Tumor Regression (time frame: Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096382, which also lists 1 linked publication.
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 28 Oct 2015.