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Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04473781
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:
This phase I/II trial investigates the side effects of interstitial brachytherapy and to see how well it works in limiting the growth of large kidney cancer masses in patients with kidney cancer that have refused or are unable to undergo surgery or ablation (unresectable/unablatable). Brachytherapy, also known as internal radiation therapy, temporarily introduces a radiation source into or near the tumor to eradicate the tumor cells. Giving brachytherapy may potentially reduce the size of the kidney cancer mass that would otherwise not be amenable to surgical management and translate into lower risk of spread.

Condition or disease Intervention/treatment Phase
Stage I Renal Cell Cancer Stage II Renal Cell Cancer Procedure: Interstitial Radiation Therapy Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the safety and feasibility of renal interstitial radiation therapy (interstitial brachytherapy). (Safety Lead-In) II. To evaluate local control of renal interstitial brachytherapy. (Expansion Phase)

SECONDARY OBJECTIVES:

I. To evaluate treatment response of the primary tumor. II. To evaluate 12 month distant progression free survival. III. To evaluate the 12 month volumetric growth of the primary tumor mass. IV. To determine biomarkers predicting response and resistance to radiation treatment.

OUTLINE:

Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.

After completion of study treatment, patients are followed up every 3 months for at least 3 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (interstitial brachytherapy)
Patients undergo interstitial brachytherapy for 1-2 fractions in the absence of disease progression or unacceptable toxicity. Patients who undergo 2 fractions may receive both fractions in the same day or on 2 separate days over 2 weeks.
 Procedure: Interstitial Radiation Therapy
Undergo interstitial brachytherapy
Other Names:
  • BRACHYTHERAPY, INTERSTITIAL
  • Implant Radiation


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) [ Time Frame: From the first administration of study therapy up to 60 days ]
    A 3+3 safety lead-in phase will be employed in order to determine the DLT for interstitial renal brachytherapy. Grading of DLTs will follow the guidelines provided in the Common Terminology Criteria for Adverse Events version 5.0 criteria.

  2. One year (12-month) linear growth rate [ Time Frame: At 1 year ]
    Adequate local control will be defined as minimal growth kinetics (=< 1 mm/year) on 1 year follow-up.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elected to undergo interstitial brachytherapy as part of conventional treatment for renal cell carcinoma
  • Biopsy proven renal cell carcinoma
  • No definitive evidence of locally advanced (nodal or tumor thrombus) or distant (metastatic) disease
  • Lesion size (maximal dimension) of 4 to 10 cm
  • Patient not a candidate for curative surgery (unwilling or unable to pursue surgery)
  • Lesion cannot be reliably treated with ablative techniques
  • Entire lesion able to be treated adequately by brachytherapy per radiation oncologist
  • Tumor predominantly solid (~ > 80%)
  • Lesion that has been observed for >= 6 months with demonstrable growth rate anticipated to be >= 4 mm/year by same imaging modality
  • Renal tumor that is amenable to percutaneous access for interstitial renal brachytherapy (Institutional Review Board [IRB])
  • Hemoglobin > 9
  • Absolute neutrophil count (ANC) >= 1500/uL (microliter)
  • Platelets >= 100,000/uL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 upper limit of normal (ULN)
  • Total bilirubin =< ULN
  • A competent immune system
  • Estimated glomerular filtration rate (eGFR) >= 30
  • Good performance status (Eastern Cooperative Oncology Group [ECOG]) < 2
  • Understanding and willingness to provide consent
  • No prior systemic treatment for kidney cancer
  • Women of childbearing potential must have negative pregnancy test at start of therapy

Exclusion Criteria:

  • Presence of an active, untreated, non-renal malignancy
  • Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months
  • History of bleeding diathesis or recent bleeding episode
  • Need for urgent treatment of renal cancer due bleeding, pain, or paraneoplastic syndrome
  • Prior surgery or radiation therapy to the operative site
  • Unwillingness to undergo clinical and laboratory monitoring and/or imaging studies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473781


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Bashir Wyatt    310-794-3448    BAWyatt@mednet.ucla.edu   
Principal Investigator: Albert J. Chang         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Albert J Chang UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04473781    
Other Study ID Numbers: 19-001258
NCI-2020-04542 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases