Cryoablation for the Treatment of Metastatic Cancer

NCT04150939 | Active Not Recruiting FDA Device

• 2 other identifiers: 2019-0502NCI-2019-07100
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional trial studies the effectiveness of adding cryoablation treatment in patients who are receiving standard of care immunotherapy to treat cancer that is has spread to other parts of the body (metastatic). Cryoablation uses a probe that freezes the tissue around the tumor to try to kill the cancer cells. Using cryoablation to treat cancerous lesions may help to kill the cancer cells.

Conditions

Metastatic Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Best objective response (complete response or partial response)

  Will be determined by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST). Best objective response will be measured by the proportion of patients who achieve complete response (CR) + partial response (PR). The proportion of patients in the efficacy evaluable population who respond (i.e., have a best response of CR or PR) will be estimated along with the corresponding 95% confidence interval, using the Clopper-Pearson exact method.

  Up to 12 months post cryoablation

Secondary Outcomes (9)

• Progression free survival (PFS)

  Up to 2 years

• Time to progression (TTP)

  Up to 2 years

• Time to progression on a ablated versus non-ablated basis

  Up to 2 years

• Disease control rate (CR + PR + stable disease [SD])

  Up to 2 years

• Duration of stable disease

  Up to 2 years

Other Outcomes (1)

• Immune parameters

  Up to 2 years

Study Arms (1)

Treatment (cryoablation)

EXPERIMENTAL

Beginning 1 week prior to the next scheduled standard of care immunotherapy infusion, patients undergo core biopsy of the lesion to be ablated and a non-ablated lesion and also undergo cryoablation. Patients undergo a mandatory second core biopsy of the non-ablated lesion at 4 weeks after cryoablation.

Procedure: Core Biopsy; Procedure: Cryosurgery; Drug: Immunotherapeutic Agent

Interventions

Core Biopsy PROCEDURE

Undergo core biospy

Also known as: core needle biopsy

Treatment (cryoablation)

Cryosurgery PROCEDURE

Undergo cryoablation

Also known as: Cryoablation, cryosurgical ablation

Treatment (cryoablation)

Immunotherapeutic Agent DRUG

Receive standard of care immunotherapy

Also known as: Biological Response Modifier, Biomodulators, BRM, Immune Mediators, Immune Modulators, Immune Regulators, Immunomodulating Agent, Immunomodulators, Immunomodulatory Agent, Immunopotentiators, Immunotherapy Agent

Treatment (cryoablation)

Eligibility Criteria

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

You may qualify if:

• Patient must have histologically or cytologically confirmed metastatic cancer and be receiving standard of care immunotherapy (PD1/PD-L1 based therapy alone or in combination with other agents (i.e. chemotherapy, targeted therapy, CTLA-4 agent)
• Patient must have had \>= 70% of planned dosing schedule of PD1/PD-L1 based therapy over the prior treatment period, defined as the previous 3 months
• For example, the expected number of doses in three months for nivolumab dosed every 2 weeks would be 6 infusions. If the patient were able to receive 5 out of the 6 doses (83% of planned dosing schedule), they would be eligible for the protocol. If the patient received only 4 out of the planned 6 doses (67% of planned dosing schedule), they would be ineligible for the protocol
• Immunotherapy treatment must have been given within the last 4 weeks without the need for systemic steroid therapy (excluding physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent)
• Patient must have demonstrated prior clinical benefit to PD1/PD-L1 based therapy followed by progression as defined by RECIST1.1: 1) partial response (PR) or complete response (CR) by RECIST1.1 (then progression by RECIST1.1) 2) stable disease (SD) x 6 months (then progression by RECIST1.1)
• Patient must have at least two lesions not previously treated with loco-regional therapy (including external beam radiation, embolization (bland or chemo), Y90, prior ablation (i.e. microwave, radiofrequency ablation, cryoablation, irreversible electroporation) that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>=10 mm with spiral computed tomography \[CT\] scan or \>= 20 mm with magnetic resonance imaging \[MRI\])
• Patient must not have a contraindication to continuing on their current immunotherapy dose regimen for at least 3 months post-cryoablation
• All lines of prior therapy accepted. Patients with resections of metastatic disease will be included
• Life expectancy of greater than 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
• Total bilirubin \< 1.5 X institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin \< 3.0 mg/dL)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X institutional upper limit of normal
• Creatinine within normal institutional limits OR - creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation or hysterectomy)
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation or hysterectomy)

You may not qualify if:

• Prior immune-related drug toxicity related adverse events that have not recovered to baseline or grade 1 (alopecia excluded)
• Patient may not be receiving any other investigational agents
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]) that require treatment with a disease modifying agent.
• The following are exceptions:
• Patients with the above disorders may be considered upon principal investigator (PI) review and allowance (i.e. patient had an autoimmune or inflammatory disorder but despite the diagnosis has been tolerating immunotherapy)
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the study physician
• Patients with celiac disease controlled by diet alone
• Current use of immunosuppressive medication including for the treatment of severe immune toxicity related to PD1/PD-L1 based therapy that precludes further treatment with immunotherapy agents. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
• Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent
• Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Biopsy, Needle; Biopsy, Large-Core Needle; Cryosurgery; Adjuvants, Immunologic; Immunologic Factors

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques; Ablation Techniques; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Alda L Tam

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: December 23, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)