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

Duke University

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Renal Cell Carcinoma

Treatments

Radiation: Stereotactic body radiation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00672178

Pro00001398

Details and patient eligibility

About

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.

Full description

In the phase I portion of this investigation, subjects will be enrolled in cohorts of three to the SBRT dose groups. Subjects will remain on sorafenib therapy during SBRT. Any change in sorafenib dosage before, during or after SBRT will be at the discretion of the subject's medical oncologist. Subjects will be assessed during, immediately after and at 4 and 8 weeks post-therapy for toxicity.

Stereotactic body radiotherapy will be given in increasingly higher dose levels each cohort until the maximum tolerated dose of radiation is determined.

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Resolution of pre-existing toxicity from prior therapy excluding alopecia and taste alteration.
Willingness and ability to comply with continuing sorafenib, visits, treatment plans, laboratory tests and study procedures.
All treated lesions must comply with SBRT dose constraints
More than 28 days since any prior systemic or local therapy for this cancer, including investigational agents and surgical procedures exclusive of sorafenib
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control)
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
Ability to understand and the willingness to sign a written informed consent.
Prothrombin time(PT) and partial thromboplastin time (PTT) within normal limits.

Exclusion criteria

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.
Any condition that impairs patient's ability to swallow whole pills.
Any malabsorption problem.