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Topoisomerase I Inhibitor
Olaparib + Temozolomide for Sarcoma
Phase 1
Waitlist Available
Led By Edwin Choy, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of measurable disease
Histologically confirmed Ewing's sarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety of an investigational drug combo and what dose is appropriate. The drugs in the combo work by interfering with cancer cells' ability to repair DNA and thus continue dividing.
Who is the study for?
This trial is for individuals with Ewing Sarcoma or Rhabdomyosarcoma who have already undergone at least one standard chemotherapy regimen. Participants must be willing to follow the study protocol, have measurable disease, and a life expectancy of at least 16 weeks. They should not be part of another clinical study within the last 21 days or have received certain treatments recently.Check my eligibility
What is being tested?
The trial is testing different doses of Olaparib in combination with Temozolomide and/or Irinotecan to find the highest safe dose against Ewing's sarcoma and rhabdomyosarcoma. It's a Phase I study which means it's early in testing these drugs together for safety and appropriate dosage levels.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, blood disorders like anemia or low white cell counts (which can increase infection risk), digestive issues, neurological symptoms such as seizures if predisposed, allergic reactions to components of Olaparib or other drugs used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured by tests.
Select...
My diagnosis is Ewing's sarcoma.
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My Ewing's sarcoma has worsened despite having at least one standard chemotherapy.
Select...
My insurance has approved temozolomide for the study period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine MTD of olaparib and irinotecan and/or temozolomide
Secondary outcome measures
Evaluate safety and tolerability of olaparib/irinotecan and/or temozolomide combination
Explore variations in PARP activity and tumor characteristics
Neoplasms
Trial Design
3Treatment groups
Experimental Treatment
Group I: TwoExperimental Treatment3 Interventions
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
Group II: ThreeExperimental Treatment2 Interventions
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
Group III: OneExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Temozolomide
2010
Completed Phase 3
~1930
Irinotecan
2017
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,262 Total Patients Enrolled
Edwin Choy, MD, PhDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
New York University School Of Medicine (Medical School)
Brigham & Women'S Hospital (Residency)
3 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that are causing symptoms and are not under control.I have not had major surgery in the last 2 weeks.I have a serious health condition that is not under control.I am not taking certain fungal, antibiotic, or protease inhibitor medications.I haven't had chemotherapy or radiotherapy (except for pain relief) in the last 2 weeks.My cancer can be measured by tests.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I still have serious side effects from past cancer treatments.I cannot swallow pills or have a stomach condition that affects medication absorption.I have active hepatitis B or C.My diagnosis is Ewing's sarcoma.I am HIV positive and on antiviral treatment.I have seizures that are not controlled by medication.My Ewing's sarcoma has worsened despite having at least one standard chemotherapy.My insurance has approved temozolomide for the study period.
Research Study Groups:
This trial has the following groups:- Group 1: Two
- Group 2: Three
- Group 3: One
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Temozolomide a secure and viable treatment option for individuals?
"According to our experts at Power, the safety score of Temozolomide is 1. This is due to its Phase I status, which implies there's limited data demonstrating both efficacy and security."
Answered by AI
What condition is Temozolomide generally employed to treat?
"Temozolomide is routinely prescribed to patients with small cell lung cancer (SCLC), but its effectiveness has also been observed in instances of disease progression, advanced directives and colorectal carcinoma."
Answered by AI
Has Temozolomide been subject to any other research endeavours?
"Currently, 614 live investigations into temozolomide are underway. Of those trials, 102 have made it to the final phase of testing with Woolloongabba in Queensland serving as a major centre for clinical study. However, there is an expansive network of 21784 institutions actively running trials on this drug."
Answered by AI
Are there still slots open to join this investigation?
"Affirmative, the clinicaltrials.gov website confirms that this medical trial is actively looking for participants. This research study was posted on July 1st 2013 and its information was most recently updated on October 27th 2021. To date, 93 individuals have been accepted at 4 different sites."
Answered by AI
How many participants have been recruited for this research?
"Indeed, according to clinicaltrials.gov, this medical trial is actively seeking participants and was first posted on July 1st 2013 with an update on October 27th 2021. 93 test subjects are being recruited from 4 separate sites."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
What site did they apply to?
Dana-Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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