Clinical trial NCT00287950: Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Infants With Neuroblastoma
Official title: Protocol for Infants With Neuroblastoma Diagnosed Under the Age of One Year
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuroblastoma
Keywords: disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-02-07
Enrollment: 120
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, the tumor may not need any treatment until it progresses. In this case, observation may be sufficient.

PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with surgery and radiation therapy works in treating infants with neuroblastoma.

Detailed description: OBJECTIVES:

* Register all children \< 12 months of age diagnosed with neuroblastoma.
* Evaluate possible prognostic factors in these patients with particular reference to the collection of biological material.
* Correlate outcome with factors other than stage in these patients.
* Determine criteria to modify treatment for some children with advanced disease without impairing survival.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 4 treatment groups according to disease stage.

* Group 1 (stage 1, 2A, or 2B disease): Patients undergo surgical resection of the tumor. Patients with paraspinal tumors may receive chemotherapy\* to shrink the tumor before undergoing surgery. Patients with local recurrence after surgery proceed to treatment as in group 3. Patients with metastatic recurrence after surgery proceed to treatment as in group 4.
* Group 2 (stage 4S disease): Patients undergo observation only. Patients with hepatomegaly or progressive disease may receive chemotherapy\*. Patients who do not respond to chemotherapy may undergo up to 4 courses of radiotherapy.
* Group 3 (stage 3 disease): Patients receive OPEC chemotherapy comprising vincristine IV and cyclophosphamide IV on day 1, cisplatin IV continuously over 24 hours on day 1, and etoposide IV over 4 hours on day 3 during courses 1, 3, and 5. Patients receive OJEC chemotherapy comprising vincristine IV, cyclophosphamide IV, etoposide IV over 4 hours, and carboplatin IV over 1 hour on day 1 during courses 2, 4, and 6. Courses repeat every 3 weeks with alternating OPEC and OJEC chemotherapy for 6 courses. Patients with residual disease then receive 4 additional courses of alternating OPEC and OJEC chemotherapy. Patients whose tumor becomes resectable after either 6 or 10 courses of chemotherapy undergo surgery. Patients with residual disease after 10 courses of chemotherapy are assessed by regular scans. Patients with disease progression on scans undergo radiotherapy. Patients with ganglioneuroma or total necrosis only with no evidence of neuroblastoma after either 6 or 10 courses of chemotherapy receive no further treatment.
* Group 4 (stage 4 disease): Patients receive alternating courses of OPEC and OJEC for 6 courses as in group 3. Patients who do not achieve metastatic complete response (CR) receive 4 additional courses of alternating OPEC and OJEC chemotherapy. Patients achieving metastatic CR after either 6 or 10 courses of chemotherapy undergo surgery to remove the tumor. Patients with macroscopic residual disease on resected specimen receive 4 additional courses of alternating OPEC and OJEC chemotherapy and then undergo biopsy. Patients with residual disease on biopsy are assessed by regular scans. Patients with disease progression on scans undergo radiotherapy. Patients with ganglioneuroma or total necrosis only after surgery with or without the 4 additional courses of chemotherapy receive no further treatment.

NOTE: \* OJEC chemotherapy with a lower dose of carboplatin

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed newly diagnosed neuroblastoma

  * Any stage disease
  * No previously treated disease
  * Must be diagnosed before the first birthday
* Must be able to start treatment before reaching 13 months of age

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospital for Sick Children
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: England
city: Bristol
country: United Kingdom
facility: Institute of Child Health at University of Bristol
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Children's Hospital, Alder Hey
state: England
city: London
country: United Kingdom
facility: Royal London Hospital
state: England
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Trust
state: England
city: London
country: United Kingdom
facility: Meyerstein Institute of Oncology at University College of London Hospitals
state: England
city: Manchester
country: United Kingdom
facility: Central Manchester and Manchester Children's University Hospitals NHS Trust
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Sir James Spence Institute of Child Health
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Children's Hospital - Sheffield
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust - Surrey
state: England
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Royal Aberdeen Children's Hospital
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Cardiff
country: United Kingdom
facility: Childrens Hospital for Wales
state: Wales
Study officials:
affiliation: University College London Hospitals
name: Penelope Brock, MD, PhD
role: STUDY_CHAIR
affiliation: Children's Hospital - Sheffield
name: Mary P. Gerrard, MBChB, FRCP, FRCPCH
affiliation: University of Newcastle Upon-Tyne
name: Andrew David J. Pearson, MD, FRCP, DCh
affiliation: St. George's Hospital
name: S. J. Keith Holmes, DO
affiliation: University of Glasgow
name: Ann Barrett
References: