Study Details

Open

Testing the addition of a new anti-cancer drug, radium-223 dichloride, to the usual treatment (cabozantinib) for advanced renal cell cancer that has spread to the bone

This study is being done to answer the following question: Can we lessen the pain you have and improve the way you live with cancer that has spread to the bone by adding a new drug to the usual drug given? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your advanced renal cell cancer. The usual approach is defined as care most people get for advanced renal cell cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Orange)

What will be asked of you

The study involves physical exams, EKGs, vital signs, blood draws for labs and research, urinalysis, variety of imaging procedures that include CT or MRI and bone scans, submission of biopsy tissue, paper questionnaires, adverse event assessments, and study drug treatment.

Incentives

Study medication

Total length of participation:
24 months

Looking for Specific Volunteers

Able to participate:

Patient is willing and able to provide written informed consent and HIPAA authorization for the release of personal health information, or have legal representation.
Patient must have a documented diagnosis of renal cell carcinoma.
Patient must have at least one metastatic bone lesion that has not been treated.
Patient had no prior treatment with the drug cabozantinib.
Patient had no major surgery within six weeks of randomization.

Not eligible if:

Patient has any issues related to previous treatments greater than Grade 1 in severity.
Patient is pregnant or nursing.
Patient has cancer that spread to brain (some exceptions).
Patients has a significant, uncontrolled illness or condition.
Patient is using any anticoagulants.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Tracy Rose
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Kidney)

IRB Number

21-0077

ClinicalTrials.gov

NCT04071223