Radiosurgery in Treating Patients With Kidney Tumors

Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer
• Intervention / Treatment: Radiation: stereotactic radiosurgery; Procedure: Renal Biopsy; Procedure: Serum Blood Markers

Detailed Description

OBJECTIVES:

Primary

• To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.

Secondary

• To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

• To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
    • Orange Village, Ohio, United States, 44122
      • UH-Chagrin Highlands
    • Westlake, Ohio, United States, 44145
      • UH-Westlake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)
• Patient is able to give and sign study specific informed consent
• No prior radiation to the treatment field
• Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
• Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
• Karnofsky status of ≥ 60%
• Signed study-specific informed consent prior to study entry

Exclusion Criteria:

• Any patient not meeting the eligibility criteria.
• Any patient with active connective tissue disease such as lupus, dermatomyositis.
• Any patient with active Crohn's disease or active ulcerative colitis.
• Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Series 1: Stereotactic radiosurgery; Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.	Radiation: stereotactic radiosurgery; Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.; Procedure: Renal Biopsy; At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.; Procedure: Serum Blood Markers; ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
Experimental: Series 2: Stereotactic radiosurgery; Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.	Radiation: stereotactic radiosurgery; Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.; Procedure: Renal Biopsy; At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.; Procedure: Serum Blood Markers; ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose of Radiosurgery	Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.	once every 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Radiographic efficacy as measured by overall (percent of participants still alive after study completion)	at 36 months from start of therapy
Progression-free Survival	Percent of participants still alive and without tumor progression at study completion	at 36 months from start of therapy
Freedom From Local Progression	Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)	at 36 months from start of therapy
Freedom to Distant Recurrence	Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)	at 36 months from start of therapy

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mitchell Machtay, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2007
• Primary Completion (Actual): March 12, 2017
• Study Completion (Actual): September 12, 2019

Study Registration Dates

• First Submitted: April 9, 2007
• First Submitted That Met QC Criteria: April 9, 2007
• First Posted (Estimate): April 11, 2007

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; stage I renal cell cancer; stage III renal cell cancer; stage II renal cell cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: CASE12806 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2010-01064 (Other Identifier: NCI/CTRP)

Drug and device information, study documents

• 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.: No