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Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

Primary Purpose

Stage I Renal Cell Cancer, Stage II Renal Cell Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Interstitial Radiation Therapy

About this trial

This is an interventional treatment trial for Stage I Renal Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCLA / Jonsson Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (interstitial brachytherapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose limiting toxicity (DLT)

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.

One year (12-month) linear growth rate

Adequate local control will be defined as minimal growth kinetics (=< 1 mm/year) on 1 year follow-up.

Secondary Outcome Measures

Full Information

NCT ID

NCT04473781

First Posted

July 13, 2020

Last Updated

June 8, 2023

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04473781

Brief Title

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

Official Title

Prospective Study of Interstitial Brachytherapy for Unresectable/Unablatable T1b/T2a Renal Masses

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 16, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage I Renal Cell Cancer, Stage II Renal Cell Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (interstitial brachytherapy)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Interstitial Radiation Therapy

Other Intervention Name(s)

BRACHYTHERAPY, INTERSTITIAL, Implant Radiation

Intervention Description

Undergo interstitial brachytherapy

Primary Outcome Measure Information:

Title

Dose limiting toxicity (DLT)

Description

Time Frame

From the first administration of study therapy up to 60 days

Title

One year (12-month) linear growth rate

Description

Adequate local control will be defined as minimal growth kinetics (=< 1 mm/year) on 1 year follow-up.

Time Frame

At 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert J Chang

Organizational Affiliation

UCLA / Jonsson Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA / Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bashir Wyatt

Phone

310-794-3448

BAWyatt@mednet.ucla.edu

First Name & Middle Initial & Last Name & Degree

Albert J. Chang

12. IPD Sharing Statement

Learn more about this trial

Interstitial Brachytherapy for the Treatment of Unresectable/Unablatable Kidney Cancer

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