Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood

NCT00868647 | Suspended Phase 2 DMC

• 1 other identifier: RFAII
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms, Benign; Neoplasms, Malignant

Outcome Measures

Primary Outcomes (1)

• Assess if quality of life was improved by RFA for the benign lesions

  baseline, 3 months and potentially 6 and 12 months following RFA

Secondary Outcomes (8)

• 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

• Evaluate the rate of short-term ablation of benign lesions produced by RFA

  baseline, 3 months and potentially 6 and 12 months following RFA

• 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

• Assess the response to RFA by malignant tumor markers (e.g. AFP)

  1, 3, 6, and 12 months following RFA

• Assess if quality of life was improved by RFA for patients with malignant lesions

  baseline, 3, 6 and 12 months

Study Arms (1)

Radiofrequency Ablation

OTHER

Procedure: Radiofrequency ablation (RFA)

Interventions

Radiofrequency ablation (RFA) PROCEDURE

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.

Radiofrequency Ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with uncontrolled infection.
• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fredric A Hoffer, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 25, 2009
• Study Start: June 1, 2007
• Primary Completion: June 1, 2012
• Last Updated: September 1, 2009

Record last verified: 2009-08

Locations

US (1)