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Olaparib + Temozolomide for Leiomyosarcoma
Study Summary
This trial is studying olaparib and temozolomide to see how well they work in treating patients with uterine leiomyosarcoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 175 Patients • NCT01055314Trial Design
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Who is running the clinical trial?
Media Library
- I am allergic to medications similar to olaparib or TMZ.You are either pregnant or breastfeeding.I am 18 years old or older.I am not taking strong or moderate drugs that affect liver enzyme CYP3A.You are currently taking part in another research study involving an experimental treatment.My cancer is a type of uterine sarcoma confirmed by tissue analysis.I am not taking any strong or moderate drugs that affect liver enzymes.I do not have any unmanaged ongoing illnesses.My advanced LMS has worsened or not tolerated previous treatment.I have HIV, am on stable treatment, no current infections, a CD4 count over 250, and an undetectable viral load.I have not had major surgery in the last 2 weeks.I do not have stomach or bowel problems affecting medicine absorption.I am 18 years old or older.My cancer cannot be removed by surgery and has spread.I am not pregnant.My cancer can be measured and safely biopsied according to specific guidelines.You are expected to live for at least 16 more weeks.My cancer is a type of uterine cancer confirmed by tissue analysis.My diagnosis is MDS, AML, or my tests show I might have these.Your platelet count is at least 100,000 per microliter, which was measured within 14 days before starting the study treatment.Your bilirubin level is not higher than the normal range set by the hospital.I am postmenopausal or cannot have children.My hemoglobin level is at least 9 g/dL without recent blood transfusions.Your blood test results show you have a normal level of a certain type of white blood cell called neutrophils.My kidney function is normal or only mildly reduced.I have LMS and it got worse or I couldn't tolerate at least one treatment.I have not been treated with PARP inhibitors or drugs like dacarbazine/temozolomide.I currently have cancer that has spread to my brain or spinal cord.I am using two reliable birth control methods if I can have children and am sexually active.I can take pills by mouth.My cancer cannot be removed by surgery and has spread.I have side effects from previous cancer treatments that are not severe.I can receive temozolomide as a standard treatment.It's been less than 28 days since my last cancer treatment.I can take care of myself but might not be able to do heavy physical work.I can take care of myself but might not be able to do active work.I had another cancer but have been free of it for 5 years or more.
- Group 1: Treatment (olaparib, temozolomide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has this type of clinical trial been done before?
"As of right now, 407 ongoing Temozolomide trials are taking place in 59 different nations and 1709 cities. The first-ever Temozolomide study was completed in 2002 by Schering-Plough. Only 60 patients were involved in the Phase 2 drug approval process. In the 19 years since that initial research project, 445 more studies have been conducted."
Are there any other clinical trials that explore Temozolomide's effects?
"Currently, 407 studies are ongoing that involve Temozolomide. 52 of those live clinical trials are in Phase 3. Although the many trials for Temozolomide originated in Rochester, Minnesota, there are now 13,942 locations running studies for this treatment worldwide."
Are we still recruiting volunteers for this research project?
"This study is not open for recruitment at the moment. The trial was first posted on June 7th, 2019 and was last updated on November 8th, 2022. There are presently 44 other studies actively recruiting participants with stage iva uterine corpus leiomyosarcoma ajcc v8 and 407 trials for Temozolomide that are looking for candidates."
What health conditions does Temozolomide usually treat?
"Temozolomide is indicated for patients with advance directives. This medication can also help those who have received nitrosourea treatment, as well as those experiencing disease progression or chemotherapy resistance."
What are some possible dangers associated with Temozolomide?
"Temozolomide is still in Phase 2 of clinical trials, so there is not yet enough evidence to support its efficacy. However, it has been shown to be safe and was given a score of 2."
How many participants are being asked to join this clinical trial?
"As of now, this particular clinical trial is not looking for more participants. Although, it's worth mentioning that the trial was first posted on 6/7/2019 and last updated on 11/8/2022. If you're interested in other studies, there are currently 44 trials actively searching for patients with stage iva uterine corpus leiomyosarcoma ajcc v8 and 407 trials for Temozolomide admitting new participants."
Are there many facilities conducting this research in North America?
"There are 15 sites conducting this trial, with locations in Gainesville, Aurora, Rochester and other cities. If you choose to participate in the trial, it is best to select the location nearest you to avoid any unnecessary travel."
Who else is applying?
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