Ewing SarcomaPhase 1ASCTNCT01969942
A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma
A Phase 1 study testing allogeneic stem cell transplantation, Clyclophosphamide and Fludarabina in people with Ewing Sarcoma, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ… Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Ewing Sarcoma
- What is being tested?
- allogeneic stem cell transplantation, Clyclophosphamide and Fludarabina
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2016
- Phase
- Phase 1
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 0-30 years with relapsed or therapy refractory Ewings sarcoma, excluding patients with brain metastases. Patients who have received a prior autologous stem cell transplant are eligible.
- Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient.
Who cannot join
- Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:
- Cardiac: Ejection Fraction less than 50 percent
- Renal: Est. Creatinine Clearance less than 50
- Hepatic: Bilirubin greater than 3.0
- Pulmonary: Diffusing Capacity for Carbon Monoxide (DLCO) less than 70 percent, or for patient who cannot cooperate with pulmonary function testing, O2 saturation less than 95 percent on room air.
- Performance status: Lansky performance less than 70; Eastern Cooperative Oncology Group (ECOG) status greater than or equal to 2
- Patients with an isolated recurrence of their tumor (in the site of primary tumor) greater than 1 year after completing therapy are excluded as these patients could be cured with local therapy alone.
- As part of the standard of care for pre-transplant evaluation subjects will be tested for exposure to viral agents such as hepatitis B, C, HTLV-1/2 and HIV. Subjects testing positive for HI may be rejected as candidates for transplantation, based on the clinical judgement of the stem cell transplant physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Hematology/Oncology University of Louisville
Louisville, Kentucky, 40202
About this study
The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient]) matched related or unrelated donors. Specifically, we will examine:
- The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
- The incidence of transplant related mortality at 100 days.
- Conditions
- Ewing Sarcoma
- Being tested
- allogeneic stem cell transplantation, Clyclophosphamide, Fludarabina, Busulfan, Melphalan
- Keywords
- Ewings sarcoma
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic stem cell transplantationBiological
ClyclophosphamideDrug
FludarabinaDrug
BusulfanDrug
MelphalanDrug
| Study group | Role | What they receive |
|---|---|---|
| allogeneic stem cell transplantation Plan A | Experimental | Subjects will receive the vaccine, Busulfan and Melphalan. Receives: Biological: allogeneic stem cell transplantation; Drug: Busulfan; Drug: Melphalan |
| allogeneic stem cell transplantation Plan B | Experimental | If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine. Receives: Biological: allogeneic stem cell transplantation; Drug: Clyclophosphamide; Drug: Fludarabina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Grade 3-4 GVHD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: No subjects meeting study inclusion were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Lucas, M.D., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969942
- Sponsor's protocol ID
- 13.0176
- Acronym
- ASCT
- Status last verified
- May 2017
- First submitted
- 21 Oct 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma
- ClinicalTrials.gov ID
- NCT01969942
- Acronym / sponsor ID
- ASCT / 13.0176
- Conditions
- Ewing Sarcoma
- Keywords
- Ewings sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects meeting study inclusion were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Oct 2013 (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.
The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient]) matched related or unrelated donors. Specifically, we will examine:
- The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
- The incidence of transplant related mortality at 100 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allogeneic stem cell transplantation Plan A | Experimental | Biological: allogeneic stem cell transplantation, Drug: Busulfan, Drug: MelphalanSubjects will receive the vaccine, Busulfan and Melphalan. |
| allogeneic stem cell transplantation Plan B | Experimental | Biological: allogeneic stem cell transplantation, Drug: Clyclophosphamide, Drug: FludarabinaIf subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients aged 0-30 years with relapsed or therapy refractory Ewings sarcoma, excluding patients with brain metastases. Patients who have received a prior autologous stem cell transplant are eligible.
- Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient.
Key exclusion criteria (8 listed)
- Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:
- Performance status: Lansky performance less than 70; Eastern Cooperative Oncology Group (ECOG) status greater than or equal to 2
- Patients with an isolated recurrence of their tumor (in the site of primary tumor) greater than 1 year after completing therapy are excluded as these patients could be cured with local therapy alone.
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 |
|---|---|---|
| allogeneic stem cell transplantation | Biological | allogeneic stem cell transplantation Plan A, allogeneic stem cell transplantation Plan B |
| Clyclophosphamide | Drug | allogeneic stem cell transplantation Plan B |
| Fludarabina | Drug | allogeneic stem cell transplantation Plan B |
| Busulfan | Drug | allogeneic stem cell transplantation Plan A |
| Melphalan | Drug | allogeneic stem cell transplantation Plan A |
Primary outcome
Development of Grade 3-4 GVHD
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
Related trials for Ewing Sarcoma
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GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
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Combination Immunotherapy Targeting Sarcomas
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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.
Kenneth Lucas, M.D. principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic stem cell transplantation, Clyclophosphamide and Fludarabina in people with Ewing Sarcoma, run by University of Louisville 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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 May 2017. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Development of Grade 3-4 GVHD (time frame: 12 months). 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 9 May 2017.