Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood

Neoplasms, Malignant Clinical Trial

Official title:

Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00868647
• Other study ID #: RFAII
• Status: Suspended
• Phase: Phase 2
• First received: March 23, 2009
• Last updated: August 28, 2009
• Start date: June 2007

Study information

• Verified date: August 2009
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign lesions.

RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

RF ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods.

To be eligible for this study, patients must have acquired lesions at < 21 years of age (central nervous system lesions are excluded from this study). Study participants will have the RFA procedure performed at Seattle Children's and will have follow-up evaluations at various time points post-RFA.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Lesion acquired in childhood (at <21 years of age)

• Any lesion location except CNS

• Any malignant tumor or metastasis

• Any benign lesion (e.g. desmoids, venous or lymphatic vascular anomalies, aneurysmal bone cysts, osteoid osteoma, tongue hypertrophy, or painful neuropathy)

• Patients with malignant disease have had histologic confirmation of disease at initial diagnosis.

• = 90 day life expectancy

• Potential benefit of RFA outweighs risk as determined by PI

• Other local tumor control measures are not recommended for malignant lesion based on review in multidisciplinary team conference or the patient refuses recommended local tumor control measures

• The patient is not expected to become short of breath at rest after RFA (forced vital capacity =33% of normal by pulmonary function tests) if pulmonary RFA is considered

Exclusion Criteria:

• Patients with uncontrolled infection.

• Patients with co-morbidities affecting inclusion criteria above.

• Patients who are pregnant and/or breastfeeding.

• Patients who had a change in chemotherapy within one month before RFA

• Patients who have planned change in chemotherapy and/or radiation therapy (to same site as RFA) interventions within the first three months following RFA.

• Patients should not be considered for pulmonary RFA if they have poorly compliant lungs (recently required mechanical ventilation) or require supplemental oxygen.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms, Benign
• Neoplasms, Malignant

Intervention

Procedure:
• Radiofrequency ablation (RFA)
Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess if quality of life was improved by RFA for the benign lesions		baseline, 3 months and potentially 6 and 12 months following RFA	No
Secondary	Assess the response to RF ablative therapy by pain relief from painful benign or malignant lesions.		baseline, 3 months and potentially 6 and 12 months following RFA	No
Secondary	Evaluate the rate of short-term ablation of benign lesions produced by RFA		baseline, 3 months and potentially 6 and 12 months following RFA	No
Secondary	Assess toxicity related to all RFA procedures using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0		within 3 months (potentially 6-12 months) following RFA	Yes
Secondary	Assess the response to RFA by malignant tumor markers (e.g. AFP)		1, 3, 6, and 12 months following RFA	No
Secondary	Assess if quality of life was improved by RFA for patients with malignant lesions		baseline, 3, 6 and 12 months	No
Secondary	Evaluate the proportion of malignant lesions that show short-term ablation produced by RFA.		3 months post Radiofrequency Ablation (RFA), as compared to 1 month post RFA imaging	No
Secondary	Determine the rate of durable ablation in malignant lesions that achieve short-term ablation by RFA		12 months post RFA	No
Secondary	Assess the time to malignant tumor progression (as defined by RECIST) of lesions treated with RFA		1, 3, 6, and 12 months post RFA	No