Radiosurgery in Treating Patients With Kidney Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Radiation: stereotactic radiosurgery
Procedure: Renal Biopsy
Procedure: Serum Blood Markers
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: February 2007
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic radiosurgery 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458484

Contacts
Contact: Rodney Ellis, MD 216-983-4769 rodney.ellis@uhhospitals.org

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
UH-Chagrin Highlands Recruiting
Orange Village, Ohio, United States, 44122
UH-Westlake Recruiting
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Rodney Ellis, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00458484     History of Changes
Other Study ID Numbers: CASE12806, P30CA043703, CASE12806, NCI-2010-01064
Study First Received: April 9, 2007
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014