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Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Infants With Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287950
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2006
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol for Infants With Neuroblastoma Diagnosed Under the Age of One Year
Study Start Date : September 1992

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma





Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287950


Locations
Show Show 22 study locations
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
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Study Chair: Penelope Brock, MD, PhD University College London Hospitals
OverallOfficial: Mary P. Gerrard, MBChB, FRCP, FRCPCH Children's Hospital - Sheffield
OverallOfficial: Andrew David J. Pearson, MD, FRCP, DCh University of Newcastle Upon-Tyne
OverallOfficial: S. J. Keith Holmes, DO St. George's Hospital
OverallOfficial: Ann Barrett University of Glasgow
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ClinicalTrials.gov Identifier: NCT00287950    
Other Study ID Numbers: CDR0000454726
CCLG-1992-05
EU-20593
CCLG-9205
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
Additional relevant MeSH terms:
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Neuroblastoma
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
Cyclophosphamide
Carboplatin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators