Stereotactic Body Radiotherapy (SBRT) and Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer (RCC)

NCT00672178 | Terminated Phase 1 Results

• 1 other identifier: Pro00001398
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of combined stereotactic body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All subjects will remain on sorafenib during SBRT.

Conditions

Renal Cell Carcinoma

Keywords

RCC; metastatic; sorafenib

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Complete and Partial Response (CR+PR)

  8 weeks

Interventions

Stereotactic body radiation RADIATION

Stereotactic body radiotherapy will be given in three cohorts of increasingly higher dose levels: Cohort 1: 6 Gy/fraction x 3 fractions (total=18 Gy) over 5 days; Cohort 2: 8 Gy/fraction x 3 fractions over 5 days; Cohort 3: 10 Gy/fraction x 3 fractions over 5 days.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Zubrod Performance Status 0 or 1
• Adequate bone marrow, liver and renal function as assessed by the following:
• Hemoglobin \> 9.0 g/dl
• Absolute neutrophil count (ANC) \> 1,500/mm3
• Platelet count \> 100,000/mm3
• Total bilirubin \< 1.5 times institutional upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the institutional ULN
• Creatinine \< 1.5 times institutional ULN
• Histologically or cytologically confirmed renal cell carcinoma, which is metastatic, unresectable or recurrent.
• Life expectancy \> 6 months
• Local recurrence or progression of primary lesion or progression, or symptomatic progression in extra-cranial, extra-pulmonary metastases while on sorafenib
• Measurable disease
• Bone metastases must have a tissue component measurable by imaging.
• No untreated brain metastases

You may not qualify if:

• Lesion in remaining (solo) kidney
• Contraindications to radiotherapy or prior radiotherapy overlapping current site(s) of disease.
• Cardiac disease: Congestive heart failure. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Active clinically serious infection
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence or history of bleeding problems
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Use of St. John's Wort or rifampin (rifampicin).
• Known or suspected allergy to sorafenib or any agent given in the course of this trial.

Sponsors & Collaborators

• Duke University: lead
• Bayer: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Early termination due to low accrual, only one subject enrolled.

Results Point of Contact

• Title: John Kirkpatrick, MD, PhD
• Organization: Duke University Medical Center

kirkp001@mc.duke.edu

919 668-7342

Study Officials

• John Kirkpatrick, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2008
• First Posted: May 6, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 12, 2017
• Results First Posted: December 15, 2010

Record last verified: 2011-01

Locations

US (1)