Study on Durvalumab and Guadecitabine for Advanced Kidney Cancer
Sponsor: Ajjai Alva, MD
ClinicalTrials ID:NCT03308396
This clinical trial is testing a combination of two drugs, Durvalumab and Guadecitabine, to see if they can help treat advanced kidney cancer. The study involves patients with metastatic renal cell carcinoma (RCC) and aims to determine the safety and effectiveness of this treatment over a period of up to 52 weeks.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is designed to evaluate the effects of combining Durvalumab, an immunotherapy drug, with Guadecitabine, a chemotherapy drug, in patients with advanced kidney cancer that has spread. Participants will receive Durvalumab through an IV every four weeks and Guadecitabine under the skin for five days in a row each month. The trial will last up to 13 cycles, or about a year, unless the cancer progresses, side effects become too severe, or the patient decides to stop.
Description
This study involves two phases: Phase Ib and Phase II. In Phase Ib, 6-12 patients will be enrolled to determine the safest dose of Guadecitabine. If the initial dose is well-tolerated, the study will proceed to Phase II with more participants.
Participants will receive Guadecitabine for the first five days of each 28-day cycle, followed by Durvalumab on the eighth day. The treatment may continue for up to 13 cycles, or 52 weeks, unless the cancer worsens, side effects become intolerable, or the patient withdraws consent.
The study will monitor for any dose-limiting toxicities (DLTs) during the first cycle. If too many patients experience severe side effects, the dose may be adjusted or the study may be stopped.
The trial aims to enroll up to 58 patients across both phases, with specific criteria for participation based on previous treatments and the type of kidney cancer.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent and agree to share health information.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Diagnosed with clear cell renal cell carcinoma that has spread.
- Have at least one measurable tumor that can be tracked using scans.
- For Cohort 1: Received up to one prior treatment, excluding certain immunotherapies.
- For Cohort 2: Received up to two prior treatments, including one specific immunotherapy that was not effective.
- Must not have had extensive radiation therapy recently.
- Must have completed any prior cancer treatment at least 14 days before joining the study and recovered from any side effects.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
- Must have a life expectancy of at least 12 weeks and weigh more than 30 kg.
- Must be willing to follow the study protocol and attend all appointments.
Exclusion Criteria
- Have an active infection requiring treatment.
- Have untreated or unstable brain metastases.
- Be pregnant or breastfeeding.
- Have a history of another cancer, unless treated and inactive for at least five years.
- Have received an investigational drug recently.
- Have certain autoimmune or inflammatory disorders.
- Be using immunosuppressive medication recently, with some exceptions.
- Be involved in planning or conducting the study.
- Be enrolled in another clinical study, unless it's observational.
- Be receiving other cancer treatments.
- Have had major surgery recently.
- Have a history of organ transplantation requiring immunosuppressive drugs.
- Have uncontrolled health conditions that could interfere with the study.
- Have active infections like tuberculosis, hepatitis, or HIV.
- Have received a live vaccine recently.
- Have allergies to study drugs.
- Weigh 30 kg or less.
- Have certain heart conditions or unresolved side effects from previous treatments.
- Have a history of lung disease requiring steroid treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Univerisity of Illinois Cancer Center | 60612 | Chicago | Illinois |
| University of Iowa Hosptials and Clinics | 52242 | Iowa City | Iowa |
| University of Michigan Comprehensive Cancer Center | 48109 | Ann Arbor | Michigan |
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| Penn State Cancer Institute | 17033 | Hershey | Pennsylvania |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.