Status:
COMPLETED
Phase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Ewing Sarcoma
Rhabdomyosarcoma
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01858168
Start Date
July 1 2013
End Date
December 12 2025
Last Update
December 19 2025
Active Locations (5)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215