Stereotactic Body Radiotherapy in Treating Lung Metastases in Patients with Ewing Sarcoma, Rhabdomyosarcoma, or Wilms Tumors

Status: Active

Description

This phase I / II trial studies the side effects and best dose of stereotactic body radiotherapy and to see how well it works in treating cancer that has spread to the lung in patients with Ewing sarcoma, rhabdomyosarcoma, or Wilms tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid)
  • Must be capable of treatment without general anesthesia
  • Lesion size 4 mm - 3 cm
  • Subjects who have lesions within 2 cm of central structures, will be eligible on a case-by-case basis * Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
  • Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be present
  • Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
  • Informed consent/assent
  • Life expectancy > 3 months
  • Pulmonary function forced expiratory volume in 1 second (FEV1) >= 50% of predicted
  • Concurrent immunotherapy is allowed

Exclusion Criteria

  • Prior whole-lung or hemi-thorax irradiation of greater than 12 gray (Gy) received less than 6 months prior to consent (focal radiotherapy to the thorax is not an exclusion)
  • Lesion larger than 3 cm in diameter
  • Patients for whom surgery would be deemed appropriate rather than radiotherapy

Locations & Contacts

Massachusetts

Boston
Boston Children's Hospital
Status: Active
Contact: Karen Jean Chayt Marcus
Phone: 617-355-8299
Email: KMARCUS@PARTNERS.ORG
Brigham and Women's Hospital
Status: Active
Contact: Karen Jean Chayt Marcus
Phone: 617-355-8299
Email: KMARCUS@PARTNERS.ORG
Dana-Farber Cancer Institute
Status: Active
Contact: Karen Jean Chayt Marcus
Phone: 617-355-8399
Email: KMARCUS@PARTNERS.ORG

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the tolerability and safety of stereotactic body radiotherapy for pulmonary metastases in pediatric patients with Ewing sarcoma, rhabdomyosarcoma or Wilms tumor and other primary renal tumors. (Phase I)

II. To evaluate disease response at 6 weeks post stereotactic body radiotherapy (SBRT) in this patient population. (Phase II)

SECONDARY OBJECTIVES:

I. To determine the feasibility of SBRT in the pediatric population (including tolerability).

II. To document the safety of the treatment.

III. To determine rate of relapse elsewhere in the lung.

IV. Best overall response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo 3 fractions of SBRT over 1-2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, 6-8 weeks, and every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Karen Jean Chayt Marcus

Trial IDs

Primary ID 15-278
Secondary IDs NCI-2016-00890
Clinicaltrials.gov ID NCT02581384