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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
This study has been completed.

First Received on January 21, 2000.   Last Updated on December 13, 2011   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004188
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: isotretinoin
Drug: melphalan
Drug: topotecan hydrochloride
Drug: vincristine sulfate
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to engrafment [ Designated as safety issue: No ]
  • CD34 content [ Designated as safety issue: No ]
  • Tumor content as measured by reverse transcriptase polymerase chain reaction [ Designated as safety issue: No ]

Study Start Date: February 2001
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:

    • Age greater than 18 months with stage IV disease, regardless of biologic factors
    • Age 12-18 months with stage IV disease meeting one of the following criteria:

      • Any unfavorable biologic feature (e.g., MYCN amplification, unfavorable pathology, and/or DNA index = 1)
      • Any biologic feature that is indeterminate, unsatisfactory, or unknown
  • At least 1 year old with the following:

    • Stage IIa/IIb with MYCN amplification (> 10) AND unfavorable pathology
    • Stage III with MYCN amplification (> 10) OR unfavorable pathology
    • Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy

      • No more than 3 weeks since progression
      • Must have been enrolled on protocol CCG-B973, COG-ANBL00B1, or POG-9047
  • Less than 1 year old with the following:

    • Stage III, IV, or IVS disease with MYCN amplification (> 10)
  • Registration on protocol COG-ANBL00B1 required within 14 days of diagnosis

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics
  • 30 and under at time of diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Inadequate hematopoiesis secondary to bone marrow involvement with > 10% tumor infiltration allowed

Hepatic:

  • Bilirubin ≤ 1.5 mg/dL
  • ALT ≤ 300 units/L

Renal:

  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance or glomerular filtration rate ≥ 60 mL/min

Cardiovascular:

  • ECG normal
  • Ejection fraction ≥ 55% by echocardiogram or MUGA OR
  • Fractional shortening ≥ 28% by echocardiogram

Other:

  • Able to tolerate peripheral blood stem cell collection
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior course of chemotherapy on the Intergroup low/intermediate risk neuroblastoma study (P9641, A3961)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior localized emergency radiotherapy to sites of life-threatening or function-threatening disease allowed

Surgery:

  • Not specified

Other

  • No other prior systemic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004188

  Show 96 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Susan G. Kreissman, MD Duke Cancer Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00004188     History of Changes
Other Study ID Numbers: CDR0000067429, COG-A3973, CCG-A3973, POG-A3973, CCG-39703, FHCRC-1631.00
Study First Received: January 21, 2000
Last Updated: December 13, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma

Additional relevant MeSH terms:
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
Cisplatin
Cyclophosphamide
Doxorubicin
Etoposide
Melphalan
Vincristine
Carboplatin
Topotecan
Lenograstim
Isotretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 12, 2012