Stereotactic Body Radiation With Nelfinavir for Oligometastases

Completed · Phase 2

Conditions studied: Oligometastases

In brief

Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.

Key facts

Study ID

NCT01728779

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

38

Starts

2014-01-08

Expected to finish

2020-12-01

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient's tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3
• Patient must have metastasis at one or more of the following sites: bone, liver, lymph node and/or lung. No more than five lesions will be treated.
• Histological confirmation of malignancy (primary or metastatic tumor).
• Patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site (see exclusion criteria 5.2.3).
• Patient must be ≥ 18 years of age.
• Patient must have a life expectancy ≥ 9 months.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patient must have normal organ and marrow function.
• Patient must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study
• Patients receiving any other investigational agents
• Patient who has had any prior radiotherapy to the treatment site(s)
• Patients taking drugs that are contraindicated with nelfinavir, including any of the following:
• Amiodarone, Quinidine, Rifampin, Dihydroergotamine, Ergonovine, Ergotamine, Methylergonovine, Hypericum perforatum (St. John's wort), Lovastatin, Simvastatin, Pimozide, Midazolam, Triazolam
• Women of child bearing potential who refuse to take a pregnancy test prior to treatment
• Participation in another concurrent treatment protocol while being treated on this protocol and through to 3 months after treatment on this protocol has ended
• Pregnant women
• Inability to understand the informed consent document
• Inability to sign the informed consent document
• Poor liver function suggestive of cirrhosis or steatohepatitis

Where it is running

• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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