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Brief Title: Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

Back to Clinical Trials

Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

INTRODUCTION

  • Org Study ID: CASE6620
  • Secondary ID: N/A
  • NCT ID: NCT04620603
  • Sponsor: Case Comprehensive Cancer Center

BRIEF SUMMARY

This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer.

DETAILED DESCRIPTION

The purpose of this study is to evaluate the effect of combining LDR with immune checkpoint inhibition in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer. This involves the addition of a treatment called brachytherapy to SOC immunotherapy. Brachytherapy is a form of radiation therapy where radioactive pellets are placed within a tumor to temporarily irradiate the tumor at a low level. This is the first time that this combination (immunotherapy and brachytherapy) has been used in humans.

The objectives of this study are to evaluate the effect of combining LDR with immunotherapy, determine safety and feasibility, generate a toxicity profile, evaluate response, and overall survival.

  • Overall Status
    Active, not recruiting
  • Start Date
    May 27, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

Primary Outcome 1 - Timeframe: 3 months after brachytherapy

Primary Outcome 2 - Measure: Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

Primary Outcome 2 - Timeframe: 6 months after brachytherapy

Primary Outcome 3 - Measure: Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

Primary Outcome 3 - Timeframe: 9 months after brachytherapy

Primary Outcome 4 - Measure: Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

Primary Outcome 4 - Timeframe: 12 months after brachytherapy

Primary Outcome 5 - Measure: Number of participants with tumor response assessed by RECIST v1.1

Primary Outcome 5 - Timeframe: 3 months after brachytherapy

Primary Outcome 6 - Measure: Number of participants with tumor response assessed by RECIST v1.1

Primary Outcome 6 - Timeframe: 6 months after brachytherapy

Primary Outcome 7 - Measure: Number of participants with tumor response assessed by RECIST v1.1

Primary Outcome 7 - Timeframe: 9 months after brachytherapy

Primary Outcome 8 - Measure: Number of participants with tumor response assessed by RECIST v1.1

Primary Outcome 8 - Timeframe: 12 months after brachytherapy

CONDITION

  • Cutaneous Malignant Melanoma
  • Renal Cell Cancer
  • Urothelial Cancer of Renal Pelvis

ELIGIBILITY

Inclusion Criteria:
* Participants must have histologically confirmed unresectable stage III or stage IV cutaneous melanoma, stage IV renal cell cancer, and stage IV urothelial cancer.

- * ECOG performance status 0-2.

- * Have measurable disease per RECIST v1.1 or iRECIST. Refer to Appendix B

- * Have the following clinical laboratory values:
* Absolute neutrophil count (ANC) ≥ 1500/ μL

- * Hgb ≥ 9 g/dL

- * Platelet count ≥ 75, 000/ μL

- * Total bilirubin ≤ 1.5 x ULN (upper limit of normal)

- * AST and ALT ≤ 2x ULN

- * Serum Creatinine < 2x ULN - * Female participants who:
* Are postmenopausal for at least 1 year before entering the screening visit, OR

- * Are surgically sterile, OR

- * Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.

- * Male participants who:
* Are surgically sterile, OR

- * Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.
Exclusion Criteria:
* Participants diagnosed with uveal melanoma

- * Participants who have been treated with whole head radiation for brain metastases

- * Invasive cancers not being treated on this trial (i.e. lymphoma that received systemic therapy) diagnosed < 3 years prior that required systemic treatment. This is intended to include a patient with melanoma who was diagnosed < 3 years prior to screening for this trial that has received antecedent systemic therapy. - * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - * Prior anti-cancer therapy for melanoma, renal cell cancer, or urothelial cancer less than 14 days prior to first dose of study treatment. - * Pregnant or nursing females - * Unwilling or unable to follow protocol requirements. - * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study treatment. - * Other active non-melanoma, non-renal cell, or non-urothelial metastatic cancers requiring systemic treatment. - * Participants currently receiving systemic corticosteroids doses over 15mg prednisone or equivalent. - * Participants with uncontrolled HIV or hepatitis.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jay Ciezki, MD

Role: Principal Investigator

Affiliation: Cleveland Clinic, Case Comprehensive Cancer Center

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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