Phase 2
Completed N=38
Stereotactic Body Radiation With Nelfinavir for Oligometastases
Oligometastases
Source: ClinicalTrials.gov NCT01728779 ↗
Enrolled (actual)
38
Serious AEs
8.1%
Results posted
Apr 2021
Primary outcomePrimary: Percentage of Participants With Freedom From Local Progression (FFLP) — 78.4 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Freedom From Local Progression (FFLP) |
78.4 | — |
| SECONDARY Total Number of Adverse Events Experienced by Participants |
20; 17; 25; 3; 3; 4 | — |
| SECONDARY Percent of Lesions With Local Control at 6 Months Post-treatment |
76.5 | — |
| SECONDARY Participants' Clinical Progress While in Follow-up in Terms of Survival |
90.7; 62.4; 57.6 | — |
| SECONDARY Quality of Life After Completion of Treatment |
— | — |
| SECONDARY Phospho/ Akt Levels With Respect to Lesion Response |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01728779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.