Ewing SarcomaPhase 1NCT01858168
Phase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma
A Phase 1 study testing Olaparib, Temozolomide and Irinotecan in people with Ewing Sarcoma and Rhabdomyosarcoma, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
This research study is a Three arm Phase I clinical trial, which tests the safety of an investigational drug or combination of drugs and also tries to define the appropriate dose of the combination of investigational drugs to use for further studies. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ewing Sarcoma, Rhabdomyosarcoma
- What is being tested?
- Olaparib, Temozolomide and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jul 2013to 12 Dec 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed Ewing's sarcoma
- Ewing's sarcoma must have progressed following at least one standard prior chemotherapy regimen
- Life expectancy of at least 16 weeks
- Willing to comply with the protocol for the duration of the study including pre- and post-treatment biopsies, undergoing treatment, scheduled visits and examinations including follow up
- Presence of measurable disease
- Prior approval from insurance company to obtain oral temozolomide for the duration of the study
Who cannot join
- Involvement in the planning and/or conduct of the study
- Previous enrollment in the present study
- Participation in another clinical study with an investigational product during the 21 days prior to first dose of olaparib and temozolomide
- Receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment
- Concurrent use of the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, protease inhibitors
- Persistent clinically significant toxicities caused by previous cancer therapy
Show all 17Show fewer
- Previously documented diagnosis of myelodysplastic syndrome (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia
- Symptomatic uncontrolled brain metastases
- Major surgery within 14 days of starting study treatment
- Considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
- Unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of study medication
- Pregnant or breastfeeding
- Known to be serologically positive for HIV and receiving antiviral therapy
- Subjects with known active hepatitis B or C
- Known hypersensitivity to olaparib or any of the excipients of the product
- Uncontrolled seizures
- Need to continue treatment with any prohibited medications or have not completed the appropriate washout period for a prohibited medication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
St. Jude's Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Phase I Study of Olaparib and Temozolomide in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma or Rhabdomyosarcoma Following Failure of Prior Chemotherapy
This research study is a Three arm Phase I clinical trial, which tests the safety of an investigational drug or combination of drugs and also tries to define the appropriate dose of the combination of investigational drugs to use for further studies. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved the combination of drugs for your type of cancer.
Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and enable them to continue dividing. Olaparib has been used in research studies with other cancers. Information from those other research studies suggests that this drug may help to treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for any use outside of research studies.
Read more
Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor, glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.
Irinotecan is approved by the FDA for the treatment of gastrointestinal cancers. It has been studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.
Laboratory studies suggest that the combination of olaparib and temozolomide and/or irinotecan may help kill Ewing sarcoma or rhabdomyosarcoma cells.
In this research study, the investigators are looking for the highest dose of the combination of olaparib and irinotecan and/or temozolomide that can be given safely. The investigators will also begin to collect information about the effects of the combination on Ewing sarcoma and rhabdomyosarcoma.
Read the detailed description
If the patient agrees to participate in this research study they will be asked to undergo some screening tests and procedures to confirm that they are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that they do not take part in the research study. If they have had some of these tests and procedures recently, they may or may not have to be repeated. These tests and procedures will include: a medical history, complete physical examination, performance status, tumor assessment, EKG, blood tests, pregnancy test, confirmation of pathology report and obtain insurance approval to receive temozolomide. If these tests show that the patient is eligible to participate in the research study, they will begin the study drug administration. If they do not meet the eligibility criteria, they will not be able to participate in this research study.
Biomarkers are substances such as genes and proteins that are important biological "indicators" that can be measured in tumor tissue. The investigators would like to look at biomarkers before and after patients receive study drug administration. Comparing the biomarkers from tissue collected before and after receiving study treatments may help us find biomarkers that are associated with response to study treatment or lack of response to study drug administration.
Before the patient starts study drug administration, if the investigators determine that the patient is healthy enough for a biopsy, the patient will undergo a biopsy to provide tumor tissue for the research tests described above. (If it is determined that the patient should not have a biopsy, they can still take part in this research study).
The investigators are looking for the highest doses of olaparib and irinotecan and/or temozolomide that can be administered safely without severe or unmanageable side effects to participants that have Ewing's sarcoma or rhabdomyosarcoma. Therefore, not everyone who participates in this research study will receive the same doses of olaparib, irinotecan, and/or temozolomide. The doses the patients get will depend on the number of participants who have been enrolled in the study before them and how well they have tolerated their doses. The investigators will tell patients how the dose level you receive compares to doses given previously in this study.
Olaparib and irinotecan and/or temozolomide will ge given in cycles of 21 days (3 weeks). Both olaparib and temozolomide are drugs that are taken by mouth. Patients will take olaparib and temozolomide on days 1-7 (week 1) of each cycle. Irinotecan is given by IV, once per day, on days 1-7 of each cycle. Patients will take olaparib twice per day and temozolomide once per day.
The investigators will give patients a drug diary to record the doses of olaparib and temozolomide that they take each day. The diary will also include special instructions for taking olaparib and temozolomide. A member of the study team will show patients how to enter their doses in the diary.
During cycle 1 patients will come to the clinic on Days 1 and 8 (weeks 1 and 2). During cycles 2-6 they will come to the clinic on Day 1 of each cycle. During cycles 8 and beyond they will come to the clinic every 9 weeks.
At each study visit patients will undergo the following procedures: a physical exam, questions about their health (problems, medications, side effects), performance status and blood tests. Additionally, during the visit on Cycle 1, Day 8 patients will have an EKG. 4-6 weeks after starting study drug administration their blood will be tested for its clotting ability on Day 1 of Cycle 2. They will also undergo a biopsy to provide tumor tissue for biomarker research tests. Every 9 weeks they wil have a CT scan or MRI to measure your tumor.
Patients will be asked to return to the clinic about 30 days after stopping study drug. At this visit the following will be done: physical exam, questions about their health, performance status and blood tests. Patients will be asked to return study drug bottles and any unused study drug at this visit.
The investigators would like to keep track of the patients' medical condition for as long as they allow. The investigators would like to do this by either calling patients on the telephone or following them at clinic visits every 3 months. Keeping in touch with patients and checking their condition helps the investigators look at the long-term effects of the research study.
- Conditions
- Ewing Sarcoma, Rhabdomyosarcoma
- Being tested
- Olaparib, Temozolomide, Irinotecan
- Medical subject headings
- Sarcoma, Ewing, Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called AZD2281
Tablets to be taken on an empty stomach twice a day.
TemozolomideDrug
Also called Temodal, SCH52365, Temodar
Tablets to be taken on an empty stomach before bedtime.
IrinotecanDrug
Also called Camptosar
Administered via IV
| Study group | Role | What they receive |
|---|---|---|
| One | Experimental | Olaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle for patients with Ewing sarcoma Receives: Drug: Olaparib; Drug: Temozolomide |
| Two | Experimental | Olaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle Irinotecan, given by IV once per day on days 1-7 of each cycle Receives: Drug: Olaparib; Drug: Temozolomide; Drug: Irinotecan |
| Three | Experimental | Olaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle for patients with Rhabdomyosarcoma Receives: Drug: Olaparib; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine MTD of olaparib and irinotecan and/or temozolomide
Determine the Maximum Tolerated Dose of combine oral administration of olaparib and temozolomide.
Measured: 30 days
Secondary outcomes (3)
Evaluate safety and tolerability of olaparib/irinotecan and/or temozolomide combination
Evaluate the safety and tolerability of combination olaparib/temozolomide as defined by CTC version 4.0
Measured: 2 years
Objective response in tumor dimensions to olaparib/irinotecan and/or temozolomide
Observe objective response in tumor dimensions to olaparib/temozolomide therapy as determined by RECIST 1.1, time of progression free survival (PFS) and overall survival (OS)
Measured: 2 years
Explore variations in PARP activity and tumor characteristics
Patients will undergo tumor biopsies before and after starting olaparib and temozolomide therapy. Genomic DNA and RNA will be isolated from these samples and slides will be made to identify specific protein levels. The investigators will assess homologous repair status by measuring gammaH2AX and Rad51 focus formation by immunofluorescence. Biomarkers for apoptosis and DNA repair that the investigators plan to analyze include but are not limited to BRCA1, MRE11A, NBS1, TDG, XPA, Rad50, 53BP1, CHEK2, and MK2.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start1 Jul 2013
- Primary completion1 Nov 2024
- Study completion12 Dec 2025
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 Massachusetts General HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin Choy, MD, Massachusetts General Hospital
- Investigators
- Edwin Choy, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858168
- Sponsor's protocol ID
- 13-115
- Status last verified
- Dec 2025
- First submitted
- 8 May 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Olaparib and Temozolomide in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma or Rhabdomyosarcoma Following Failure of Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT01858168
- Acronym / sponsor ID
- 13-115
- Conditions
- Ewing Sarcoma, Rhabdomyosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 21 May 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.
This research study is a Three arm Phase I clinical trial, which tests the safety of an investigational drug or combination of drugs and also tries to define the appropriate dose of the combination of investigational drugs to use for further studies. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved the combination of drugs for your type of cancer.
Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and enable them to continue dividing. Olaparib has been used in research studies with other cancers. Information from those other research studies suggests that this drug may help to treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for any use outside of research studies.
Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor, glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.
Irinotecan is approved by the FDA for the treatment of gastrointestinal cancers. It has been studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.
Laboratory studies suggest that the combination of olaparib and temozolomide and/or irinotecan may help kill Ewing sarcoma or rhabdomyosarcoma cells.
In this research study, the investigators are looking for the highest dose of the combination of olaparib and irinotecan and/or temozolomide that can be given safely. The investigators will also begin to collect information about the effects of the combination on Ewing sarcoma and rhabdomyosarcoma.
Detailed description
If the patient agrees to participate in this research study they will be asked to undergo some screening tests and procedures to confirm that they are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that they do not take part in the research study. If they have had some of these tests and procedures recently, they may or may not have to be repeated. These tests and procedures will include: a medical history, complete physical examination, performance status, tumor assessment, EKG, blood tests, pregnancy test, confirmation of pathology report and obtain insurance approval to receive temozolomide. If these tests show that the patient is eligible to participate in the research study, they will begin the study drug administration. If they do not meet the eligibility criteria, they will not be able to participate in this research study.
Biomarkers are substances such as genes and proteins that are important biological "indicators" that can be measured in tumor tissue. The investigators would like to look at biomarkers before and after patients receive study drug administration. Comparing the biomarkers from tissue collected before and after receiving study treatments may help us find biomarkers that are associated with response to study treatment or lack of response to study drug administration.
Before the patient starts study drug administration, if the investigators determine that the patient is healthy enough for a biopsy, the patient will undergo a biopsy to provide tumor tissue for the research tests described above. (If it is determined that the patient should not have a biopsy, they can still take part in this research study).
The investigators are looking for the highest doses of olaparib and irinotecan and/or temozolomide that can be administered safely without severe or unmanageable side effects to participants that have Ewing's sarcoma or rhabdomyosarcoma. Therefore, not everyone who participates in this research study will receive the same doses of olaparib, irinotecan, and/or temozolomide. The doses the patients get will depend on the number of participants who have been enrolled in the study before them and how well they have tolerated their doses. The investigators will tell patients how the dose level you receive compares to doses given previously in this study.
Olaparib and irinotecan and/or temozolomide will ge given in cycles of 21 days (3 weeks). Both olaparib and temozolomide are drugs that are taken by mouth. Patients will take olaparib and temozolomide on days 1-7 (week 1) of each cycle. Irinotecan is given by IV, once per day, on days 1-7 of each cycle. Patients will take olaparib twice per day and temozolomide once per day.
The investigators will give patients a drug diary to record the doses of olaparib and temozolomide that they take each day. The diary will also include special instructions for taking olaparib and temozolomide. A member of the study team will show patients how to enter their doses in the diary.
During cycle 1 patients will come to the clinic on Days 1 and 8 (weeks 1 and 2). During cycles 2-6 they will come to the clinic on Day 1 of each cycle. During cycles 8 and beyond they will come to the clinic every 9 weeks.
At each study visit patients will undergo the following procedures: a physical exam, questions about their health (problems, medications, side effects), performance status and blood tests. Additionally, during the visit on Cycle 1, Day 8 patients will have an EKG. 4-6 weeks after starting study drug administration their blood will be tested for its clotting ability on Day 1 of Cycle 2. They will also undergo a biopsy to provide tumor tissue for biomarker research tests. Every 9 weeks they wil have a CT scan or MRI to measure your tumor.
Patients will be asked to return to the clinic about 30 days after stopping study drug. At this visit the following will be done: physical exam, questions about their health, performance status and blood tests. Patients will be asked to return study drug bottles and any unused study drug at this visit.
The investigators would like to keep track of the patients' medical condition for as long as they allow. The investigators would like to do this by either calling patients on the telephone or following them at clinic visits every 3 months. Keeping in touch with patients and checking their condition helps the investigators look at the long-term effects of the research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One | Experimental | Drug: Olaparib, Drug: TemozolomideOlaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle for patients with Ewing sarcoma |
| Two | Experimental | Drug: Olaparib, Drug: Temozolomide, Drug: IrinotecanOlaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle Irinotecan, given by IV once per day on days 1-7 of each cycle |
| Three | Experimental | Drug: Olaparib, Drug: TemozolomideOlaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle for patients with Rhabdomyosarcoma |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed Ewing's sarcoma
- Ewing's sarcoma must have progressed following at least one standard prior chemotherapy regimen
- Life expectancy of at least 16 weeks
- Willing to comply with the protocol for the duration of the study including pre- and post-treatment biopsies, undergoing treatment, scheduled visits and examinations including follow up
- Presence of measurable disease
Key exclusion criteria (17 listed)
- Involvement in the planning and/or conduct of the study
- Previous enrollment in the present study
- Participation in another clinical study with an investigational product during the 21 days prior to first dose of olaparib and temozolomide
- Receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment
- Concurrent use of the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, protease inhibitors
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 |
|---|---|---|
| OlaparibAlso: AZD2281Tablets to be taken on an empty stomach twice a day. | Drug | One, Three, Two |
| TemozolomideAlso: Temodal, SCH52365, TemodarTablets to be taken on an empty stomach before bedtime. | Drug | One, Three, Two |
| IrinotecanAlso: CamptosarAdministered via IV | Drug | Two |
Primary outcome
Determine MTD of olaparib and irinotecan and/or temozolomide
Time frame: 30 days
Determine the Maximum Tolerated Dose of combine oral administration of olaparib and temozolomide.
3 secondary outcomes
Evaluate safety and tolerability of olaparib/irinotecan and/or temozolomide combination
Time frame: 2 years
Objective response in tumor dimensions to olaparib/irinotecan and/or temozolomide
Time frame: 2 years
Explore variations in PARP activity and tumor characteristics
Time frame: 2 years
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 19 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Edwin Choy, MD, PhD principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olaparib, Temozolomide and Irinotecan in people with Ewing Sarcoma and Rhabdomyosarcoma, run by Massachusetts General Hospital at 5 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?
The sponsor lists 6 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 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?
Determine MTD of olaparib and irinotecan and/or temozolomide (time frame: 30 days). 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 19 Dec 2025.