Study on Orellanine for Treating Advanced Clear-Cell or Papillary Kidney Cancer
Sponsor: Oncorena AB
ClinicalTrials ID:NCT05287945
This clinical trial is testing the safety and initial effectiveness of a new treatment called orellanine for patients with advanced clear-cell or papillary kidney cancer that has spread to other parts of the body.
Patient Parameters
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Program Overview
This study aims to evaluate how safe and effective orellanine is for treating patients with advanced kidney cancer, specifically clear-cell or papillary types, that has spread beyond the kidney. Up to 75 patients will participate in this study, which is divided into three parts. The first part involves gradually increasing the dose for each patient, followed by a phase to determine the best dose, and finally expanding the study to more patients to confirm the findings.
Description
This clinical trial is designed to test a new treatment called orellanine in patients with advanced kidney cancer that has spread to other parts of the body. The study will include up to 75 participants and is divided into three phases. In the first phase, patients will receive increasing doses of orellanine to find the safest dose. The second phase will involve more patients to confirm the best dose, and the third phase will expand the study to further evaluate the treatment's effectiveness. Participants will be closely monitored for any side effects and how well the treatment works against their cancer.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate.
- Diagnosed with advanced clear-cell or papillary kidney cancer, with no other suitable treatments available or if the patient chooses not to undergo conventional therapy.
- For certain parts of the study, the cancer must be measurable by scans.
- Must be in relatively good health, with a performance status score between 0 and 2.
- Must be 18 years or older.
- Expected to live at least 3 more months.
- Must have acceptable blood and liver function based on specific lab tests.
- Must be on regular dialysis for at least three months.
- Both the kidney and cancer doctors must agree that the treatment will not significantly affect the patient's dialysis needs.
- Women who can become pregnant and men must use two forms of effective birth control during the study and for a specified time after the last dose.
- Women must have a negative pregnancy test before starting the study.
- Must be willing to follow all study procedures, including travel and scheduled visits.
Exclusion Criteria
- Have had another type of cancer within the last two years, except for certain skin cancers or low-risk prostate cancer.
- Have received radiation therapy within two weeks before starting the study.
- Have had immunotherapy within the last six months.
- Have taken other cancer treatments within two weeks before starting the study.
- Have not recovered from side effects of previous cancer treatments to a mild level, except for hair loss or mild nerve damage.
- Have taken any other experimental treatments within four weeks before starting the study.
- Are pregnant or breastfeeding.
- Have uncontrolled medical conditions or infections that could interfere with the study.
- Have a heart rhythm issue with a QTc interval of 470 milliseconds or more.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Washington University in St. Louis | 63130 | St Louis | Missouri |
| University of Texas - MD Anderson Cancer Center | 77030 | Houston | Texas |
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