Experimental drug cocktail targets tough childhood cancers in adults
NCT ID NCT01858168
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs, olaparib and temozolomide (with or without irinotecan), in 49 adults with Ewing sarcoma or rhabdomyosarcoma that had come back or spread after standard chemotherapy. The main goal was to find the safest dose and see if the combo could shrink tumors. The drugs work by blocking cancer cells' ability to repair their DNA, making them more likely to die. This was an early-phase trial focused on safety, not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
49 people
The number who actually took part.
- Started
-
Jul 2013
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
16 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ewing sarcoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
-
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
-
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
-
St. Jude's Children's Research Hospital
Memphis, Tennessee, 38105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A pill that blocks RAS: can it help children whose tumors came back?
- Can a new drug tame ewing sarcoma when others fail?
- Can an antibody drug outsmart resistant Ewing's sarcoma?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Can engineered immune cells tackle childhood sarcoma?
- Can AI read tumor slides to outsmart childhood cancer?