Ewing's SarcomaPhase 1/2NCT00492141
Aerosol L9-NC and Temozolomide in Ewing's Sarcoma
A Phase 1/2 study testing Temozolomide and L9-NC in people with Ewing's Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the feasibility and toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide. 2. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Ewing's Sarcoma
- What is being tested?
- Temozolomide and L9-NC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2009
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients, 10 years of age or older, with primary or metastatic cancer in the lungs, who have failed or progressed on front line therapy and have no standard therapies available for treatment are eligible. Patients may also have disease in other sites, but must have current lung involvement to be eligible.
- Patients should have adequate bone marrow function, defined by: absolute peripheral granulocyte count of >/= 1500 cells/mm^3, platelet count > 100,000 platelets/mm^3, and Hgb > 8.0 g/dl. For patients with documented bone marrow involvement, the following counts are acceptable for enrollment: absolute peripheral granulocyte count of > 1000 cells/mm^3 , platelet count > 75,000 platelets/mm^3.
- Patients should have adequate hepatic function, defined by: total bilirubin < 2 mg/dl and ALT or AST < 2x upper limit of normal.
- Patients should have adequate renal function, defined by serum creatinine </= 2 mg/dl.
- Patients must have adequate pulmonary function, as defined by a pulmonary function test with: >/= 50% FVC, >/= 50% FEV1 and >/= 50% DLCO of predicted values
Who cannot join
- Patients with symptomatic brain metastases.
- Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
- Patients receiving concurrent chemotherapy.
- Patients may not receive concurrent radiation therapy to the chest during cycles 1-3. Radiation therapy to disease in other areas of the body is permissible at any time, but such lesions will not be evaluable for response. Although patients who have received prior radiation to the chest are eligible, patients should be at least 4 weeks from prior radiation to the chest. Any chest lesion treated with radiation must have progressed to be considered measurable for this study.
- Patients with severe medical problems such as uncontrolled diabetes mellitus (glucose consistently greater than 200 mg/dl, or Hemoglobin A1c greater than 8%) or symptomatic cardiovascular disease (New York class III) or active infections requiring IV antibiotics are not eligible for this trial.
- Patients requiring oxygen.
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
Official title: Aerosol Liposomal 9-Nitro-20(S)-Camptothecin (L9-NC) and Temozolomide in Ewing's Sarcoma and Other Solid Tumors With Lung Involvement
Primary Objectives:
- To determine the feasibility and toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide.
- To determine the effectiveness of L9-NC given by aerosol in combination with temozolomide in patients with solid tumors involving the lungs.
Read the detailed description
L9-NC and temozolomide each work by blocking certain tumor cell functions, which can keep tumor cells from growing.
If you are found to be eligible to take part in this study, you will be given the L9-NC aerosol (an inhaled spray) by mouth through a face mask for Cycle 1 of therapy. You will receive L9-NC over about 30 minutes once a day, for 5 days in a row. This will be done for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment. A treatment cycle lasts for 4 weeks.
Your first L9-NC aerosol treatment, during Cycle 1, will be given at M.D. Anderson. You may receive the rest of your treatments at home, if you experienced no bad side effects with the first aerosol treatment.
During Cycle 2 of therapy, if you have not experienced any intolerable side effects, you will be given temozolomide. You will receive temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will also continue to receive the L9-NC aerosol over about 30 minutes once a day, for 5 days in a row, for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment.
During Cycle 3 of therapy, if you have not experienced any intolerable side effects, you will continue to be given temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will receive the L9-NC aerosol twice a day, about 12 hours apart, over about 30 minutes, for 5 days in a row, for 2 weeks. If you experience any bad side effects during Cycle 2, your dose of temozolomide will be decreased, and you will continue to receive L9-NC aerosol once a day (instead of twice a day), for 5 days in a row, for 2 weeks.
For all further cycles of treatment, if you experienced any bad side effects during Cycle 3, you will receive L9-NC only once a day, instead of twice a day. If you are already receiving L9-NC only once a day, and you experience intolerable side effects in Cycle 3, you will be taken off this study.
You will be shown how to do spirometry (a lung test that measures how much and how fast air moves out of the lungs) to monitor the safety of your therapy. You will be asked to do this after each treatment cycle, for the first 2 cycles. If your dose of L9-NC is increased to twice a day, you will also be asked to do spirometry after the second dose of the day during Cycle 3. For future cycles, you will be asked to do spirometry after the last dose of L9-NC, on the first day of each week of treatment. The results of spirometry will need to be sent to M.D. Anderson by telephone, after each test. The results will be sent electronically. They will be reviewed every day after they are received, and you will be contacted if there are abnormal results. Your doctor may also perform additional spirometry as needed.
You will be examined by a doctor before the second and third cycle of therapy (every 4 weeks). You will have blood drawn (about 2 tablespoons) every week during the first 2 to 3 cycles of therapy. After Cycle 3 of therapy, blood tests (about 2 tablespoons) will be done before each cycle of therapy. Chest x-rays, CT chest scans, and any other imaging studies, as done at the beginning of this study, will be done to measure your disease and will be repeated after every 3 cycles of therapy. You will also have a breathing function test, if the doctor thinks it is necessary.
If your tumor size decreases during this treatment, you may have other therapy performed, such as surgery, radiation, or radiofrequency ablation, outside of this study. If the treatment in this study alone, or in combination with other therapy, results in complete disappearance of your disease, your treatment on this study may continue for up to 6 more cycles.
You will be taken off this study if your disease gets worse or you experience any intolerable side effects. If you are taken off this study for intolerable side effects, you will be followed-up for 30 days after treatment ends or until your side effects go away.
If you have a complete remission, chest x-rays, CT chest scans, and any other imaging studies, as done at the beginning of this study, will be done to look for disease about every 3 months after completion of treatment.
This is an investigational study. L9-NC is authorized by the FDA for use in research only. Temozolomide is approved by the FDA. The use of these drugs together in this study is experimental. Up to 40 patients will take part in this study. All will be enrolled at M.D. Anderson.
- Conditions
- Ewing's Sarcoma
- Being tested
- Temozolomide, L9-NC
- Keywords
- Ewing's Sarcoma, Lung Involvement, Temozolomide, Temodar, Aerosol Liposomal 9-Nitro-20(S)-Camptothecin, Aerosol L9-NC, L9-NC
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
Cycle 2, Dose Level 1 = 100 mg/m^2 by mouth (PO) Daily, Days 1-5 Prior to L9-NC; Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, advance to 100 mg/m^2 PO Every 12 Hours, Days 1-5 Prior to L9-NC. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2; Cycle 4 and beyond = Patients will continue on dose level 1 or 2 as given in cycle 3.
L9-NCDrug
Also called 9-Nitro-20(S)-Camptothecin, Aerosol L9-NC
Cycle 1 = Administered by aerosol 5 consecutive days per week for 2 weeks. A total of 10 ml of 0.4 mg/ml in an aerosol reservoir delivered over approximately 30 minutes per day given once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
Cycle 2, Dose Level 1 = Week 1, doses 1-5 preceded by temozolomide. Continue L9-NC once a day, 5 days a week, for 2 weeks, followed by 2 weeks off.
Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, due to drug, during cycle 2, L9-NC may be increased to twice daily, approximately 12 hours apart. Week 1, the morning dose on days 1-5 preceded by temozolomide. L9-NC will be given twice a day, 5 days a week, for 2 weeks, followed by 2 weeks off. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2.
Cycle 4 and beyond, patients will continue on dose level 1 or 2 as given in cycle 3.
| Study group | Role | What they receive |
|---|---|---|
| L9-NC + Temozolomide | Experimental | Liposomal 9-nitro-20(S)-camptothecin (L9-NC) alone, total 10 ml of 0.4 mg/ml in aerosol reservoir once a day for 5 days in row each 2 weeks, followed by 2 weeks off; then in combination with Temozolomide 100 mg/m^2 oral/day for Cycle 2 Days 1-5. Receives: Drug: Temozolomide; Drug: L9-NC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Profile
Toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide. All toxicities evaluated according to NCI Common Toxicity Criteria, Version 3.0 and recorded prior to each cycle of therapy.
Measured: From baseline to end study period (3 years)
Secondary outcomes (1)
Number of Participants with Response According to Response Evaluation Criteria In Solid Tumors (RECIST)
Response by tumor measurements (centimeters) using RECIST criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or > new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.
Measured: Baseline till after three cycles of therapy (approximately 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionMay 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing's SarcomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia E. Herzog, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492141
- Sponsor's protocol ID
- 2005-0889
- Status last verified
- Aug 2012
- First submitted
- 26 Jun 2007
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosol Liposomal 9-Nitro-20(S)-Camptothecin (L9-NC) and Temozolomide in Ewing's Sarcoma and Other Solid Tumors With Lung Involvement
- ClinicalTrials.gov ID
- NCT00492141
- Acronym / sponsor ID
- 2005-0889
- Conditions
- Ewing's Sarcoma
- Keywords
- Ewing's Sarcoma, Lung Involvement, Temozolomide, Temodar, Aerosol Liposomal 9-Nitro-20(S)-Camptothecin, Aerosol L9-NC, L9-NC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jun 2007 (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.
Primary Objectives:
- To determine the feasibility and toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide.
- To determine the effectiveness of L9-NC given by aerosol in combination with temozolomide in patients with solid tumors involving the lungs.
Detailed description
L9-NC and temozolomide each work by blocking certain tumor cell functions, which can keep tumor cells from growing.
If you are found to be eligible to take part in this study, you will be given the L9-NC aerosol (an inhaled spray) by mouth through a face mask for Cycle 1 of therapy. You will receive L9-NC over about 30 minutes once a day, for 5 days in a row. This will be done for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment. A treatment cycle lasts for 4 weeks.
Your first L9-NC aerosol treatment, during Cycle 1, will be given at M.D. Anderson. You may receive the rest of your treatments at home, if you experienced no bad side effects with the first aerosol treatment.
During Cycle 2 of therapy, if you have not experienced any intolerable side effects, you will be given temozolomide. You will receive temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will also continue to receive the L9-NC aerosol over about 30 minutes once a day, for 5 days in a row, for 2 weeks. Doctors will then monitor you for safety for another 2 weeks after treatment.
During Cycle 3 of therapy, if you have not experienced any intolerable side effects, you will continue to be given temozolomide by mouth once a day, for 5 days in a row, during the first week of each cycle. You will receive the L9-NC aerosol twice a day, about 12 hours apart, over about 30 minutes, for 5 days in a row, for 2 weeks. If you experience any bad side effects during Cycle 2, your dose of temozolomide will be decreased, and you will continue to receive L9-NC aerosol once a day (instead of twice a day), for 5 days in a row, for 2 weeks.
For all further cycles of treatment, if you experienced any bad side effects during Cycle 3, you will receive L9-NC only once a day, instead of twice a day. If you are already receiving L9-NC only once a day, and you experience intolerable side effects in Cycle 3, you will be taken off this study.
You will be shown how to do spirometry (a lung test that measures how much and how fast air moves out of the lungs) to monitor the safety of your therapy. You will be asked to do this after each treatment cycle, for the first 2 cycles. If your dose of L9-NC is increased to twice a day, you will also be asked to do spirometry after the second dose of the day during Cycle 3. For future cycles, you will be asked to do spirometry after the last dose of L9-NC, on the first day of each week of treatment. The results of spirometry will need to be sent to M.D. Anderson by telephone, after each test. The results will be sent electronically. They will be reviewed every day after they are received, and you will be contacted if there are abnormal results. Your doctor may also perform additional spirometry as needed.
You will be examined by a doctor before the second and third cycle of therapy (every 4 weeks). You will have blood drawn (about 2 tablespoons) every week during the first 2 to 3 cycles of therapy. After Cycle 3 of therapy, blood tests (about 2 tablespoons) will be done before each cycle of therapy. Chest x-rays, CT chest scans, and any other imaging studies, as done at the beginning of this study, will be done to measure your disease and will be repeated after every 3 cycles of therapy. You will also have a breathing function test, if the doctor thinks it is necessary.
If your tumor size decreases during this treatment, you may have other therapy performed, such as surgery, radiation, or radiofrequency ablation, outside of this study. If the treatment in this study alone, or in combination with other therapy, results in complete disappearance of your disease, your treatment on this study may continue for up to 6 more cycles.
You will be taken off this study if your disease gets worse or you experience any intolerable side effects. If you are taken off this study for intolerable side effects, you will be followed-up for 30 days after treatment ends or until your side effects go away.
If you have a complete remission, chest x-rays, CT chest scans, and any other imaging studies, as done at the beginning of this study, will be done to look for disease about every 3 months after completion of treatment.
This is an investigational study. L9-NC is authorized by the FDA for use in research only. Temozolomide is approved by the FDA. The use of these drugs together in this study is experimental. Up to 40 patients will take part in this study. All will be enrolled at M.D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L9-NC + Temozolomide | Experimental | Drug: Temozolomide, Drug: L9-NCLiposomal 9-nitro-20(S)-camptothecin (L9-NC) alone, total 10 ml of 0.4 mg/ml in aerosol reservoir once a day for 5 days in row each 2 weeks, followed by 2 weeks off; then in combination with Temozolomide 100 mg/m^2 oral/day for Cycle 2 Days 1-5. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All patients, 10 years of age or older, with primary or metastatic cancer in the lungs, who have failed or progressed on front line therapy and have no standard therapies available for treatment are eligible. Patients may also have disease in other sites, but must have current lung involvement to be eligible.
- Patients should have adequate bone marrow function, defined by: absolute peripheral granulocyte count of >/= 1500 cells/mm^3, platelet count > 100,000 platelets/mm^3, and Hgb > 8.0 g/dl. For patients with documented bone marrow involvement, the following counts are acceptable for enrollment: absolute peripheral granulocyte count of > 1000 cells/mm^3 , platelet count > 75,000 platelets/mm^3.
- Patients should have adequate hepatic function, defined by: total bilirubin < 2 mg/dl and ALT or AST < 2x upper limit of normal.
- Patients should have adequate renal function, defined by serum creatinine </= 2 mg/dl.
- Patients must have adequate pulmonary function, as defined by a pulmonary function test with: >/= 50% FVC, >/= 50% FEV1 and >/= 50% DLCO of predicted values
Key exclusion criteria (6 listed)
- Patients with symptomatic brain metastases.
- Pregnant women or nursing mothers. Patients of child bearing potential must use adequate contraception.
- Patients receiving concurrent chemotherapy.
- Patients may not receive concurrent radiation therapy to the chest during cycles 1-3. Radiation therapy to disease in other areas of the body is permissible at any time, but such lesions will not be evaluable for response. Although patients who have received prior radiation to the chest are eligible, patients should be at least 4 weeks from prior radiation to the chest. Any chest lesion treated with radiation must have progressed to be considered measurable for this study.
- Patients with severe medical problems such as uncontrolled diabetes mellitus (glucose consistently greater than 200 mg/dl, or Hemoglobin A1c greater than 8%) or symptomatic cardiovascular disease (New York class III) or active infections requiring IV antibiotics are not eligible for this trial.
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 |
|---|---|---|
| TemozolomideAlso: TemodarCycle 2, Dose Level 1 = 100 mg/m^2 by mouth (PO) Daily, Days 1-5 Prior to L9-NC; Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, advance to 100 mg/m^2 PO Every 12 Hours, Days 1-5 Prior to L9-NC. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2; Cycle 4 and beyond = Patients will continue on dose level 1 or 2 as given in cycle 3. | Drug | L9-NC + Temozolomide |
| L9-NCAlso: 9-Nitro-20(S)-Camptothecin, Aerosol L9-NCCycle 1 = Administered by aerosol 5 consecutive days per week for 2 weeks. A total of 10 ml of 0.4 mg/ml in an aerosol reservoir delivered over approximately 30 minutes per day given once a day, 5 days a week, for 2 weeks, followed by 2 weeks off. Cycle 2, Dose Level 1 = Week 1, doses 1-5 preceded by temozolomide. Continue L9-NC once a day, 5 days a week, for 2 weeks, followed by 2 weeks off. Cycle 3, Dose Level 2 = If the patient has no toxicity greater than grade 2, due to drug, during cycle 2, L9-NC may be increased to twice daily, approximately 12 hours apart. Week 1, the morning dose on days 1-5 preceded by temozolomide. L9-NC will be given twice a day, 5 days a week, for 2 weeks, followed by 2 weeks off. If the patient is not able to advance to dose level 2, the patient may continue at dose level 1 as in cycle 2. Cycle 4 and beyond, patients will continue on dose level 1 or 2 as given in cycle 3. | Drug | L9-NC + Temozolomide |
Primary outcome
Toxicity Profile
Time frame: From baseline to end study period (3 years)
Toxicity profile of administering liposomal 9-Nitro-20-(S)-Camptothecin (L9-NC) by aerosol alone and in combination with temozolomide. All toxicities evaluated according to NCI Common Toxicity Criteria, Version 3.0 and recorded prior to each cycle of therapy.
1 secondary outcome
Number of Participants with Response According to Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: Baseline till after three cycles of therapy (approximately 9 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- UT MD 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.
Cynthia E. Herzog, MD 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 1/2 study testing Temozolomide and L9-NC in people with Ewing's Sarcoma, 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 6 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 2 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity Profile (time frame: From baseline to end study period (3 years)). 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 2 Aug 2012.