Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy

NCT01986829 | Terminated Phase 2 Results DMC FDA Device

• 1 other identifier: 201309108
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well cryoablation, radiofrequency ablation, or microwave ablation works in treating patients with metastatic sarcoma stable on chemotherapy. Cryoablation kills tumor cells by freezing them. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Microwave ablation kills tumor cells by heating them to several degrees above body temperature.

Conditions

Osteosarcoma; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Rate

  Defined as the percentage of patients with no progression (local recurrence of an ablated lesion or the appearance of a new lesion) after ablation.

  3 months

Secondary Outcomes (9)

• Overall Survival (OS)

  Assessed up to 5 years

• Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy

  Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

• Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea

  Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

• Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse

  Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

• Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life

  Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)

Study Arms (1)

Treatment (ablation)

EXPERIMENTAL

* Patients undergo cryoablation, radiofrequency ablation, or microwave ablation of each lesion. * Patients complete pain survey (BPI-Short form) and quality of life questionnaires (FACT-G7)

Device: Microwave ablation; Device: Cryoablation; Device: Radiofrequency ablation; Other: BPI-Short form; Other: FACT-G7

Interventions

Microwave ablation DEVICE

* Microwave ablation will be predominantly used on metastatic soft tissue lesions and will include use of Covidien's Evident™ MWA System. Microwave ablation is performed under ultrasound, CT, and occasional fluoroscopic guidance with CT fluoroscopy available for intermittent use in probe placement and CT monitoring of ablation. * Microwave antennae from Covidien (Mansfield, MA) are either introduced into the lesion co-axially through a bone biopsy needle or directly into the lesions that are amenable to such, i.e., soft tissue, lung, liver, and large lytic lesions with extensive bone destruction.

Treatment (ablation)

Cryoablation DEVICE

* Cryoablation is performed under ultrasound, CT and occasional fluoroscopic guidance with CT fluoroscopy available for intermittent use in cyroprobe placement and CT monitoring of ablation. * Cryoprobes from Endocare Inc. (Irvine CA) or Galil Medical (Arden Hills MN) are either introduced into the lesion co-axially through a bone biopsy needle or directly into the lesions that are amenable to such, i.e., soft tissue, lung, liver, and large lytic lesions with extensive bone destruction.

Also known as: Cryosurgery, Cryosurgical ablation

Treatment (ablation)

Radiofrequency ablation DEVICE

-Radiofrequency ablation will be predominantly used on metastatic spine lesions and will include use of the Dfine STAR ablation probe. This probe will be placed coaxially through an introducer needle into the spinal metastatic lesion.

Treatment (ablation)

BPI-Short form OTHER

-Prior to ablation, 1 day post-ablation, 1 month post-ablation (from first procedure if more than 1 is done), and time of disease progression

Treatment (ablation)

FACT-G7 OTHER

-Prior to ablation, 1 day post-ablation, 1 month post-ablation (from first procedure if more than 1 is done), and time of disease progression

Treatment (ablation)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed high-grade metastatic sarcoma that has been stable on 6-12 cycles of one chemotherapeutic regimen (cytotoxic or biologic) although a change in chemotherapy is allowed if it is a result of toxicity/tolerability rather than progression. A patient must not have evidence of progression at any time while on chemotherapy in order to be eligible for this trial.
• Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, PET CT, or MRI exam.
• At least 18 years of age.
• ECOG performance status ≤ 2 (Karnofsky ≥60%)
• Normal bone marrow and organ function as defined below:
• Leukocytes ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcl
• Platelets ≥ 100,000/mcl
• Total bilirubin ≤ 1.5 x IULN or 3x IULN with normal ALT and AST in patients with Gilbert's disease
• AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
• Creatinine less than the institutional upper limit of normal OR creatinine clearance ≥ 50 mL/min/1.73 m2
• INR\<1.5 or patient off Coumadin at the time of ablation
• No more than 10 treatable lesions as evaluated by an experienced interventional oncologic radiologist for eligibility and lesion accessibility as the ablation of more than 10 lesions becomes technically infeasible. These lesions must be treated in a two- to three-week time period from initial interventional radiology evaluation. Lung and liver lesions can range from 1 cm to 7 cm for a single lesion and no greater than 5 cm for multiple lesions. There are no size criteria for the osseous lesions.
• The lesions will be amenable to a safe, ultrasound/computed tomographic/fluoroscopic guided percutaneous approach. The targeted metastases must be sufficiently separable from the central nervous system, major peripheral motor nerves, bowel, and bladder. All lesions must be amenable to treatment.
• If patients have received radiation therapy, there must be a one-month washout period.

You may not qualify if:

• History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or localized prostate cancer.
• Receiving any other investigational agents simultaneously or within 3 weeks following ablation procedure.
• Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and/or breastfeeding.
• Patients whose treatment plans include continuing chemotherapy after ablation as per the treating physician, as ablation therapy is meant to serve as maintenance therapy in lieu of chemotherapy.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Hirbe AC, Jennings J, Saad N, Giardina JD, Tao Y, Luo J, Berry S, Toeniskoetter J, Van Tine BA. A Phase II Study of Tumor Ablation in Patients with Metastatic Sarcoma Stable on Chemotherapy. Oncologist. 2018 Jul;23(7):760-e76. doi: 10.1634/theoncologist.2017-0536. Epub 2018 Feb 27.

  PMID: 29487221 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Osteosarcoma; Sarcoma

Interventions

Cryosurgery; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Radiofrequency Therapy; Therapeutics

Results Point of Contact

• Title: Brian Van Tine, M.D.
• Organization: Washington University School of Medicine

bvantine@wustl.edu

314-362-5817

Study Officials

• Brian Van Tine, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 11, 2013
• First Posted: November 19, 2013
• Study Start: February 3, 2014
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)