A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) in High Risk Abdominal Neuroblastoma

NCT01440283 | Terminated Phase 2 Results

• 1 other identifier: NBIMRT
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

High risk neuroblastoma (NB) is an aggressive, prevalent non-brain cancer derived from nerve cells of the body. It mostly affects infants, and more children die from this tumor each year than are cured. Standard therapy includes a combination of chemotherapy, surgery, bone marrow transplant, radiation and immunotherapy. NB is very sensitive to radiation, but due to it's aggressive spread pattern, radiation use is currently limited by toxicity. This study seeks to improve delivery of radiation to reduce toxicity by quantifying outcomes, and measuring differences in renal toxicity and organ motion so that radiation can be focused more effectively against tumor while sparing normal tissues and reducing side-effects.

Conditions

Abdominal Neuroblastoma

Keywords

Neuroblastoma; Radiation Therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Failed to Reach Local-regional Control

  Measured from start of radiation therapy to date of local-regional failure or last follow-up.

  2 years after last patient enrollment

• Pattern of Local-regional Failure.

  Categorical measurements of local-regional failure.

  2 years after last patient enrollment

Secondary Outcomes (2)

• Quantify the Range of Organ Movement During the Breathing Phase Measured by 4-dimensional MRI (4DMRI) and 4DCT.

  Baseline and approximately 2 weeks following initiation of irradiation.

• Quantify (in mm/cm) the Range of Target Movement During the Breathing Phase Measured by 4DMRI and 4DCT.

  Baseline and approximately 2 weeks following initiation of irradiation.

Study Arms (1)

Treatment

EXPERIMENTAL

Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen will be eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients will begin the planning process for abdominal irradiation. Interventions: Intensity Modulated Radiation Therapy (IMRT)

Radiation: Intensity Modulated Radiation Therapy (IMRT)

Interventions

Intensity Modulated Radiation Therapy (IMRT) RADIATION

IMRT delivery will follow current conventional volume-targeting guidelines, however, appropriate application within the abdomen will be determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease is required. Concurrent neuro-hormonal tests, cytokine analyses, functional and morphologic imaging will generate novel data describing the acute and chronic effects of radiotherapy within the abdomen.

Also known as: IMRT

Treatment

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mucositis ≤ Grade 2
• Patient stable on room air
• Albumin \> 3 g/dL without albumin infusions for 1 week
• Serum creatinine should be \< 1.5 x normal for age
• Lansky score \>60
• Risk Strata Eligibility: Patients between 6 months and 18 years of age with newly diagnosed abdominal primary, high-risk neuroblastoma defined as one of the following:
• International agreement on staging (INSS) stage 2a or 2b with N-myc (MYCN) amplification (greater than four-fold increase in (MYCN) signals as compared to reference signals), regardless of age or additional biologic features
• INSS stage 3 with either MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features, or for age \> 18 months with unfavorable pathology, regardless of MYCN status
• INSS stage 4 with MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features, or for age \>18 months with unfavorable pathology, regardless of MYCN status
• INSS stage 4S with MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features
• Exceptional Cases Still Considered Eligible:
• Prior palliative radiotherapy if not related to the primary site, however, children receiving definitive radiotherapy as a part of the pre-enrollment regimen are ineligible. Prior treatment regimen must follow the guidelines of an applicable high-risk neuroblastoma regimen. Slight variations from this timeframe are acceptable based on recovery of blood counts or other concerns left to the discretion of the treating radiation oncologist.
• Patients receiving surgical management elsewhere are still considered eligible to enroll on protocol therapy for assessment of the primary local control objective, renal motion and toxicity assessment. Target motion objectives may be excluded from the analysis of these patients.

You may not qualify if:

• Patients who have received prior definitive radiotherapy at or adjacent to the primary abdominal tumor bed.
• Patients who are unable to cooperate with acquisition of 4-dimensional computed tomography (4DCT), computed tomography (CT) or magnetic resonance imaging- (MRI)-based imaging procedures.
• Patients with known brain metastases.
• Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
• Pregnant women.
• Mediastinal primary tumors.
• Patients receiving surgery elsewhere, or at St. Jude within 3 months prior to study activation, are excluded from assessment of target and motion objectives. However they are still eligible to enroll for assessment of the primary objective, renal motion and toxicity.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Mayo Clinic: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neuroblastoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Limitations and Caveats

The study was closed to accrual in January 2014 due to the principal investigator leaving St. Jude. It was expected to re-open to accrual, however, in September 2015, the decision was made to permanently close the trial to participant enrollment.

Results Point of Contact

• Title: Chia-ho Hua, PhD
• Organization: St. Jude Children's Research Hospital

chia-ho.hua@stjude.org

901-595-3610

Study Officials

• Chia-Ho Hua, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 26, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 3, 2016
• Results First Posted: February 4, 2016

Record last verified: 2015-11

Locations

US (1)