Cryoablation, Radiofrequency Ablation, or Microwave Ablation in Treating Patients With Metastatic Sarcoma Stable on Chemotherapy
Condition: Osteosarcoma; Sarcoma
MeSH terms: Sarcoma; Osteosarcoma
Intervention: Microwave ablation; Cryoablation; Radiofrequency ablation; BPI-Short form; FACT-G7
Intervention description: 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.; 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.; -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.; -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; -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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.