Study on Low-Dose-Rate Brachytherapy Combined with Immunotherapy for Advanced Melanoma, Kidney, and Bladder Cancer
Sponsor: Case Comprehensive Cancer Center
ClinicalTrials ID:NCT04620603
This clinical trial is exploring a new treatment approach by adding low-dose-rate brachytherapy to standard immunotherapy for patients with advanced melanoma, kidney, and bladder cancer. The study aims to assess the safety and effectiveness of this combination.
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Program Overview
The study is testing a new treatment method that combines low-dose-rate brachytherapy with standard immunotherapy for patients with advanced stages of melanoma, kidney cancer, and bladder cancer. Brachytherapy involves placing small radioactive pellets inside the tumor to deliver low-level radiation directly to it. This is the first time this combination is being tested in humans, and the study will evaluate its safety, feasibility, and impact on tumor response and patient survival.
Description
This clinical trial is investigating the effects of combining low-dose-rate brachytherapy with immune checkpoint inhibitors in patients with advanced melanoma, kidney cancer, and bladder cancer. Brachytherapy is a type of radiation therapy where tiny radioactive pellets are placed inside the tumor to deliver radiation directly to it. The study aims to determine if this combination is safe and effective in treating these cancers. Researchers will monitor participants for any side effects, how well the cancer responds to the treatment, and overall survival rates. This is the first time this treatment combination is being tested in humans, and the study will provide valuable insights into its potential benefits.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced melanoma, kidney cancer, or bladder cancer that cannot be surgically removed.
- Be in relatively good health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable cancer as defined by standard criteria.
- Meet specific blood test requirements, including:
- Neutrophil count of at least 1500/μL
- Hemoglobin level of at least 9 g/dL
- Platelet count of at least 75,000/μL
- Total bilirubin level within 1.5 times the normal limit
- Liver enzymes (AST and ALT) within 2 times the normal limit
- Serum creatinine level less than 2 times the normal limit
- Female participants must be postmenopausal, surgically sterile, or agree to use effective contraception during the study and for 90 days after the last dose.
- Male participants must be surgically sterile or agree to use effective contraception during the study and for 90 days after the last dose.
Exclusion Criteria
- Have mucosal or uveal melanoma.
- Have received whole head radiation for brain metastases.
- Have had other invasive cancers requiring systemic treatment within the last 3 years.
- Have uncontrolled illnesses such as active infections, heart failure, unstable chest pain, irregular heartbeats, or psychiatric conditions that would interfere with the study.
- Have received anti-cancer therapy for melanoma, kidney cancer, or bladder cancer within 14 days before starting the study treatment.
- Are pregnant or breastfeeding.
- Are unwilling or unable to follow the study requirements.
- Have any condition that the study doctor believes makes them unsuitable for the study.
- Have other active cancers requiring systemic treatment.
- Are currently taking high doses of corticosteroids (over 15mg of prednisone or equivalent).
- Have uncontrolled HIV or hepatitis.
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