Clinical trial NCT01986829: Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy
Official title: Tumor Ablation in Metastatic Sarcoma Stable on Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteosarcoma
Sarcoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of ablation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Patient (or legally authorized representative if applicable) must be able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Progression-free Rate
timeFrame: 3 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Assessed up to 5 years
measure: Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
measure: Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
measure: Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
measure: Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
measure: Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
measure: Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
measure: Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
measure: Change in Pain Following Ablation Procedure
timeFrame: Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Brian Van Tine, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.