Study Comparing Cediranib Maleate and Olaparib to Bevacizumab for Treating Recurrent Glioblastoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02974621
This clinical trial is testing two different treatments to see which works better for patients with glioblastoma that has returned. The study compares the combination of cediranib maleate and olaparib with bevacizumab, a standard treatment, to see which is more effective in stopping tumor growth.
Patient Parameters
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Program Overview
This study aims to find out if the combination of two drugs, cediranib maleate and olaparib, is more effective than bevacizumab in treating glioblastoma that has come back after initial treatment. Cediranib maleate and olaparib work by blocking certain enzymes that help tumor cells grow, while bevacizumab is an immunotherapy that helps the immune system attack cancer cells. The trial will measure how long patients live without their cancer getting worse and compare the safety and effectiveness of these treatments.
Description
The main goal of this study is to compare how well the combination of cediranib maleate and olaparib works against bevacizumab in patients with recurrent glioblastoma. Researchers will look at how long patients live without their cancer progressing and overall survival rates. They will also assess the safety of the drug combination and study various biological markers to understand how the treatments work.
Participants will be randomly assigned to one of two groups. One group will take olaparib and cediranib maleate by mouth daily, while the other group will receive bevacizumab through an IV every two weeks. Both treatments will continue in 28-day cycles as long as they are effective and do not cause unacceptable side effects.
After finishing the study treatment, patients will have follow-up visits for up to three years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have evidence of glioblastoma that has returned, confirmed by a brain scan or biopsy.
- Previously treated with radiation and temozolomide.
- At least 12 weeks since last radiation treatment, unless the new tumor is outside the previous radiation area or confirmed by biopsy.
- Only first or second recurrence of glioblastoma is eligible.
- Must have stopped other cancer treatments for a specified time before starting the study.
- Must have resolved any side effects from previous treatments, except hair loss.
- Willing to provide a tissue sample for research if available.
- Must have a performance status score of 60 or higher, indicating the ability to care for oneself.
- Life expectancy of at least 3 months.
- Meet specific blood count and organ function requirements.
- Women must not be pregnant or breastfeeding and must use effective birth control during the study.
- Men must also use effective birth control during the study and for 6 months after treatment.
- Must understand and agree to the study requirements and sign a consent form.
Exclusion Criteria
- Cannot have participated in another clinical trial or used investigational drugs within the past 4 weeks.
- Cannot have used PARP inhibitors or drugs affecting the VEGF pathway before.
- Cannot have uncontrolled high blood pressure or require more than three medications to manage it.
- Cannot have had recent severe heart or vascular issues, such as a heart attack or stroke.
- Cannot have a history of certain abdominal or lung conditions.
- Cannot have other active cancers, except for certain skin or cervical cancers treated with curative intent.
- Cannot have significant heart or vascular disease.
- Cannot have had major surgery or significant injury within 28 days before starting the study.
- Cannot have uncontrolled illnesses or psychiatric conditions that would interfere with the study.
- Cannot be taking certain medications that interact with the study drugs.
- Cannot be pregnant or breastfeeding due to potential risks to the baby.
- Cannot have HIV and be on antiretroviral therapy due to potential drug interactions.
- Cannot use certain herbal supplements or other anti-cancer therapies during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Smilow Cancer Hospital-Orange Care Center | 06477 | Orange | Connecticut |
| Smilow Cancer Hospital-Torrington Care Center | 06790 | Torrington | Connecticut |
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