Tremelimumab With or Without Cryoablation in Treating Patients With Metastatic Kidney Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02626130
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Metastatic Renal Cell Cancer
  • Stage IV Renal Cell Cancer AJCC v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryosurgery — PROCEDURE
    Undergo cryoablation
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgery
  • Tremelimumab — BIOLOGICAL
    Given IV

Study Details

This randomized pilot clinical trial studies the side effects of tremelimumab with or without tissue cryoablation in treating patients with kidney cancer that has spread to other places in the body. Tremelimumab binds to a protein called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is found on the surface of T cells (a type of white blood cell). Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. It is not yet known whether tremelimumab with or without cryoablation is effective in treating patients with kidney cancer.

Key Dates

Start date
Mar 30, 2016
Status verified
Jul 2022
Primary completion
Jun 20, 2022
Completion
Jun 20, 2022

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (tremelimumab)
    Patients receive tremelimumab IV over 60 minutes at weeks 1 and 5. Within 4-6 weeks later, patients undergo surgery or biopsy. After surgery or biopsy, patients receive tremelimumab IV Q4W for 3 doses, and then every Q12W in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B (tremelimumab and cryoablation)
    Patients undergo cryoablation and receive tremelimumab IV over 60 minutes at weeks 1 (2-6 days after cryoablation) and 5. Within 4-6 weeks later, patients undergo surgery or biopsy. After surgery or biopsy, patients receive tremelimumab IV Q34W for 3 doses, and then Q12W in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

Related Studies