Phase II Study of Proton Radiation Therapy for Neuroblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shannon MacDonald, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02112617
First received: April 10, 2014
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma.

Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the top of the kidneys. However, it can also occur in other areas where groups of nerve cells exist, such as other areas of the abdomen, neck and near the spine.

Conventional radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors. In this research study, the investigators are looking at another type of radiation called proton radiation which is known to spare surrounding tissues and organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring radiation. This may reduce side effects that patients would normally experience with standard radiation therapy or other means of delivering proton radiation therapy.

In this research study, the investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment. The investigators will also be assessing the late side effects experienced by participants in each treatment group.


Condition Intervention Phase
Neuroblastoma
Ganglioneuroblastoma
Radiation: Proton Beam Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Proton Radiation Therapy for Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma. Specifically, cardiac, pulmonary, gastrointestinal, endocrine, growth and second malignancies will be described.

  • To evaluate acute and subacute toxicities of proton radiotherapy in place of photon radiation for patients with neuroblastoma. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate acute and subacute toxicities of proton radiotherapy in place of photon radiation for patients with neuroblastoma. Specifically, nausea, vomiting, diarrhea, radiation pneumonitis and skin toxicity will be described.


Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Overall survival rates [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: June 2014
Estimated Study Completion Date: March 2028
Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Beam Radiation Therapy (PBRT)
Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.
Radiation: Proton Beam Radiation Therapy
Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.

Detailed Description:

Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.

The radiation therapy will be outpatient at Massachusetts General Hospital.

During radiation therapy, the participant will have the following weekly assessments and procedures:

  • Physical Exam
  • Assess for any side effects
  • Routine blood tests (weekly or at least every other week)

Post-treatment Follow Up Visit (s):

The participant will be asked to return to the clinic 3-6 months after their last dose of radiation therapy and then annually for up to 5 years for the following procedures:

  • Medical History
  • Physical Exam
  • Assess for side effects
  • Lung Function Tests (if required)
  Eligibility

Ages Eligible for Study:   3 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
  • Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites. If tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other DF/HCC institution is required, but preliminary report only required prior to enrollment. If no tumor tissue was obtained, urinary catecholamine metabolites are required.
  • Participants do not need to have measurable disease at the time of radiation. Age ≥ 3 and ≤ 25 years at the time of diagnosis because this study evaluates this disease entity in the pediatric population which may differ from the adult population.
  • Life expectancy of greater than 12 months.
  • ECOG performance status ≤2 (Karnofsky ≥60%, Lansky ≥60%, see Appendix A).
  • Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.
  • Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.
  • Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.

Exclusion Criteria:

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • Patients will be ineligible if any prior therapeutic radiation therapy > 500 cGy has been delivered.
  • Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112617

Contacts
Contact: Shannon M MacDonald, MD (617) 726-2000 smacdonald@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Shannon M. MacDonald, MD    617-726-2000    smacdonald@partners.org   
Principal Investigator: Shannon M. MacDonald, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Shannon M. MacDonald, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Shannon MacDonald, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02112617     History of Changes
Other Study ID Numbers: 13-443
Study First Received: April 10, 2014
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Neuroblastoma
Childhood neuroblastoma
Ganglioneuroblastoma
Pediatric neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Ganglioneuroblastoma
Ganglioneuroma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 28, 2014