Study on Olaparib for Treating Advanced Glioma, Cholangiocarcinoma, or Solid Tumors with IDH1 or IDH2 Mutations
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03212274
This clinical trial is testing how well the drug olaparib works in treating patients with advanced glioma, cholangiocarcinoma, or other solid tumors that have specific genetic mutations (IDH1 or IDH2) and have spread or not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to see if olaparib can help stop the growth of tumor cells in patients with advanced glioma, cholangiocarcinoma, or other solid tumors that have specific genetic mutations (IDH1 or IDH2). These tumors have either spread from their original location or have not responded to other treatments. Olaparib works by blocking certain enzymes that tumor cells need to grow.
Description
The main goal of this study is to find out how well olaparib works in shrinking tumors in patients with specific genetic mutations (IDH1 or IDH2) in their cancer. Patients will be divided into three groups based on their type of cancer: glioma, cholangiocarcinoma, or other solid tumors.
Secondary goals include understanding how long patients live without their cancer getting worse, how long they live overall, and how long the treatment keeps working. The study will also check the safety and side effects of olaparib.
Patients will take olaparib pills twice a day in 28-day cycles, as long as the cancer does not get worse and there are no severe side effects. During the study, patients will have regular scans, blood tests, and possibly tumor biopsies to monitor their response to the treatment.
After finishing the treatment, patients will be followed up for 30 days to check their health and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must understand the study and agree to participate, with the option for a caregiver to assist if needed.
- Diagnosed with glioma, cholangiocarcinoma, or another solid tumor that has specific IDH1 or IDH2 mutations and has not responded to standard treatments.
- Tumors must be accessible for biopsy, and patients must agree to have biopsies done.
- Must be willing to provide extra blood samples for research.
- Must have measurable disease based on specific medical criteria.
- For glioma patients, specific criteria about the tumor's progression and treatment history apply.
- Must be 18 years or older.
- Must have good overall health and specific blood test results within normal ranges.
- Must not have had previous treatment with olaparib or similar drugs.
- Women of childbearing potential must use effective contraception during the study and for one month after.
- Men must agree to use contraception during the study and for three months after.
Exclusion Criteria
- Cannot participate if involved in planning or conducting the study.
- Cannot have participated in another clinical study with an investigational product recently.
- Cannot have had previous treatment with PARP inhibitors like olaparib.
- Cannot have other active cancers within the last five years, with some exceptions.
- Cannot have certain heart conditions or be taking specific medications that interact with olaparib.
- Cannot have unresolved side effects from previous cancer treatments.
- Cannot have uncontrolled brain metastases or other serious medical conditions.
- Cannot be pregnant or breastfeeding.
- Cannot have certain infections like active hepatitis or HIV.
- Cannot have had a recent major surgery or certain blood transfusions.
- Cannot have a history of allergic reactions to olaparib or similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC Irvine Health Cancer Center-Newport | 92627 | Costa Mesa | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Stanford Cancer Institute Palo Alto | 94304 | Palo Alto | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
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