Radiosurgery in Treating Patients With Kidney Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00458484
First received: April 9, 2007
Last updated: February 3, 2014
Last verified: February 2014

April 9, 2007
February 3, 2014
February 2007
April 2014   (final data collection date for primary outcome measure)
Maximum tolerated dose of radiosurgery (Phase I) [ Time Frame: once every 4 weeks ] [ Designated as safety issue: Yes ]
Acute Radiation Toxicity ≥ grade 3 in the Gastrointestinal and renal/genitourinary categories of the common terminology criteria for adverse events 4.0 (CTCAE) will be considered dose limiting. The maximum tolerated dose will be one dose level below which the adverse event, as described above, occurred.
Maximum tolerated dose of radiosurgery
Complete list of historical versions of study NCT00458484 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: at 36 months from start of therapy ] [ Designated as safety issue: No ]
    Number of patients still alive after study completion
  • Disease-free survival [ Time Frame: at 36 months from start of therapy ] [ Designated as safety issue: No ]
  • Time to local progression [ Time Frame: at 36 months from start of therapy ] [ Designated as safety issue: No ]
  • Time to distant failure (Phase II) [ Time Frame: at 36 months from start of therapy ] [ Designated as safety issue: No ]
  • Overall survival
  • Disease-free survival
  • Time to local progression
  • Time to distant failure
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
  • Radiation: 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. The radiation treatment planning and evaluation details are appended.

    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.

  • 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: Stereotactic radiosurgery
Interventions:
  • Radiation: stereotactic radiosurgery
  • Procedure: Renal Biopsy
  • Procedure: Serum Blood Markers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
Not Provided
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Rodney Ellis, MD 216-983-4769 rodney.ellis@uhhospitals.org
United States
 
NCT00458484
CASE12806, P30CA043703, CASE12806, NCI-2010-01064
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Rodney Ellis, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP