Stereotactic Body Radiation Therapy in Treating Patients With Metastatic or Recurrent Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen byStanley Liauw

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This pilot clinical trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with kidney cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.

Eligibility Criteria

Inclusion Criteria

Patients must have normal organ and marrow function within 30 days of registration, as defined below: Absolute neutrophil count >= 500/mcL, Hemoglobin >= 8.0 g/dL, Platelets >= 50,000/mcL, Total bilirubin within normal institutional limits, Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal if liver metastases are present

Women of childbearing potential must have a negative pregnancy test within 14 days of registration

Patients must have the ability to understand and the willingness to sign a written informed consent document

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Exclusion Criteria

Patients with radiographic or clinical findings of spinal cord compression or cauda equina syndrome with neurologic deficit thought to be due to malignancy

Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration; Transmural myocardial infarction within the last 6 months prior to registration; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration; Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease if the liver is involved with metastatic disease; Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment

You have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the last month before enrolling in the study.

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Treatment Details

Interventions

Stereotactic Body Radiation Therapy (Radiation Therapy)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Stereotactic body radiation therapyExperimental Treatment1 Intervention

Patients undergo stereotactic body radiation therapy on day 1 over 3 times a week for 28 days in the absence of disease progression or unacceptable toxicity.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for: