Stereotactic Body Radiation With Nelfinavir for Oligometastases

NCT01728779 | Completed Phase 2 Results DMC

• 2 other identifiers: J12137NA_00069585
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oligometastases

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Freedom From Local Progression (FFLP)

  To determine the 6-month Freedom From Local Progression rate (measured as a percentage of participants) in participants treated with radiosensitizer nelfinavir used concurrently with 15 Gy of stereotactic body radiation therapy (SBRT) delivered in 1 fraction in patients with oligometastatic disease. FFLP is defined as the percent of participants who were free from progression at the 6 month time point.

  6 months

Secondary Outcomes (5)

• Total Number of Adverse Events Experienced by Participants

  1 year

• Percent of Lesions With Local Control at 6 Months Post-treatment

  6 months

• Participants' Clinical Progress While in Follow-up in Terms of Survival

  18 months

• Quality of Life After Completion of Treatment

  3 years

• Phospho/ Akt Levels With Respect to Lesion Response

  3 months

Study Arms (1)

Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)

EXPERIMENTAL

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.

Drug: Nelfinavir; Radiation: Stereotactic Body Radiation (SBRT)

Interventions

Nelfinavir DRUG

Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.

Also known as: Viracept

Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)

Stereotactic Body Radiation (SBRT) RADIATION

15 Gy dose (per lesion site) of SBRT will be administered

Also known as: Stereotactic Body Radiation, SBRT

Nelfinavir w/Stereotactic Body Radiation Therapy (SBRT)

Eligibility Criteria

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

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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Interventions

Nelfinavir; Radiosurgery

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dana Kaplin
• Organization: Johns Hopkins University

dkaplin1@jhmi.edu

410-614-3950

Study Officials

• Phuoc Tran, M.D.

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: November 20, 2012
• Study Start: January 8, 2014
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 12, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-06

Locations

US (1)