Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

• ClinicalTrials.gov Identifier: NCT02581384
• Recruitment Status: Recruiting
• First Posted: October 21, 2015
• Last Update Posted: March 22, 2019
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Karen J Marcus, MD FACR, Boston Children’s Hospital

Study Description

Brief Summary:

This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

Condition or disease	Intervention/treatment	Phase
Ewing Sarcoma; Rhabdomyosarcoma; Wilms Tumor; Osteosarcoma; Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nos; Renal Tumor; Rhabdoid Tumor; Clear Cell Renal Cell Carcinoma; Sarcoma; Sarcoma, Ewing; Soft Tissue Sarcoma	Radiation: Stereotactic Body Radiotherapy (SBRT)	Phase 1; Phase 2

Detailed Description:

This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of these cancers in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
• Study Start Date: May 2016
• Estimated Primary Completion Date: February 2025
• Estimated Study Completion Date: February 2029

Arms and Interventions

Arm

Intervention/treatment

Experimental: Stereotactic Body Radiotherapy; Stereotactic Body Radiotherapy (SBRT); Different dose levels will be used in the two cohorts.; Ewing sarcoma, rhabdomyosarcoma, and others with non-renal tumor patients begin at a pre-determined dose per protocol.; Wilms tumors or other primary renal tumors renal tumor patients begin at pre-determined dose per protocol. The two cohorts will be enrolling patients independently and simultaneously.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Outcome Measures

Primary Outcome Measures :

1. Dose Limiting Toxicity [ Time Frame: 6 Months ]
   The Phase I portion will evaluate the toxicity profile of each dose level and determine whether a given dose level could move forward to the Phase II portion
2. Overall Response [ Time Frame: 6 weeks ]
   Response after 6 weeks will be assessed

Secondary Outcome Measures :

1. Best Overall Response [ Time Frame: 2 years ]
   The Kaplan and Meier method will be used to measure relapse time elsewhere in the lung. All patients who takes part in the treatment will be monitored for toxicity, and the percent of patients with various toxicities will be calculated for each dose level.

Eligibility Criteria

• Ages Eligible for Study: up to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)
• Age ≤ 21 years;
• Must be capable of treatment without general anesthesia
• Lesion size 8 mm - 3 cm
• Subjects who have lesions within 2 cm of central structures, will be eligible on a case by-case basis
• 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 FEV1 ≥ 50% of predicted;
• Concurrent immunotherapy is allowed

Exclusion Criteria:

• Prior whole-lung or hemi-thorax irradiation of greater than 12 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

Contacts and Locations

Contacts

Contact: Karen J Marcus, MD; 617-732-8783; karen_marcus@dfci.harvard.edu

Contact: Cierra W Zaslowe-Dude, BA; 6175828987; czaslowe-dude@bwh.harvard.edu

Locations

United States, Massachusetts

Boston Children's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Karen Marcus, MD 617-355-8399

Principal Investigator: Karen J Marcus, MD

Sub-Investigator: Katherine Janeway, MD

Sub-Investigator: Elizabeth Mullen, MD

Dana Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Karen Marcus, MD 617-355-8399

Principal Investigator: Karen Marcus, MD

Dana Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Karen J Marcus, MD 617-355-8399

Principal Investigator: Karen J Marcus, MD

Sub-Investigator: Katherine Janeway, MD

Sub-Investigator: Elizabeth Mullen, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Karen Marcus, MD; Dana-Farber Cancer Institute

More Information

• Responsible Party: Karen J Marcus, MD FACR, Karen J Marcus, M.D., Boston Children’s Hospital
• ClinicalTrials.gov Identifier: NCT02581384 History of Changes
• Other Study ID Numbers: 15-278
• First Posted: October 21, 2015
• Last Update Posted: March 22, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Karen J Marcus, MD FACR, Boston Children’s Hospital:

Ewing Sarcoma; Rhabdomyosarcoma; Wilms Tumor; Rhabdomyosarcoma of Mediastinum; Ewing's Sarcoma Metastatic; Ewing Family of Tumors; Ewing's Tumor Metastatic; Osteosarcoma, Metastatic; Osteosarcoma in Children; Rhabdoid Tumor; Lung Metastasis; Radiation for Children; SBRT for children; Stereotactic Body Radiotherapy; Pulmonary Metastasis; Lung Metastasis in Children; Pulmonary Metastasis in Children; Comfort Care; Palliative Care

Additional relevant MeSH terms:

Neoplasm Metastasis; Sarcoma; Carcinoma, Renal Cell; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Wilms Tumor; Rhabdoid Tumor; Neoplasms; Neoplastic Processes; Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn