Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025649
• Other study ID #: CDR0000068982
• Secondary ID: EURO-INF-NB-STUD
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2001
• Last updated: September 16, 2013
• Start date: July 1999
• Est. completion date: March 2009

Study information

• Verified date: December 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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 or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.

Description:

OBJECTIVES:

• Determine the survival of infants with newly diagnosed stage II, III, IV, or IVS neuroblastoma with MYCN amplification treated with etoposide, carboplatin, cyclophosphamide, doxorubicin, and vincristine followed by surgery and busulfan and melphalan with autologous peripheral blood stem cell or bone marrow transplantation.

• Determine whether there are prognostic criteria that could be used in future therapeutic stratification of these patients.

OUTLINE: This is a multicenter study.

Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses. Patients then receive CADO chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for 2 courses.

Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days. Patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not mobilize sufficient cells undergo bone marrow harvest.

Patients eligible for surgery undergo surgical resection. Patients with stage IV disease with less than complete response of metastatic disease after initial chemotherapy are removed from the study.

Beginning within 2 weeks after surgery, patients receive 1 additional course of VP-CARBO chemotherapy followed by 1 additional course of CADO chemotherapy.

After at least 3 weeks, patients receive high-dose chemotherapy comprising busulfan IV over 24 hours on days -7 to -3 and melphalan IV on day -2. PBSC or bone marrow are reinfused on day 0.

At least 2 months after the completion of high-dose chemotherapy and bone marrow or PBSC transplantation, patients undergo radiotherapy to the primary site, according to preoperative imaging studies. Patients are treated with oral tretinoin after megatherapy.

Patients are followed within 6 months and then annually for 5 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed stage II, III, IV, or IVS neuroblastoma or ganglioneuroblastoma

• MYCN amplification (i.e., at least 10 copies)

PATIENT CHARACTERISTICS:

Age:

• Under 12 months at diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Biological:
• filgrastim

Drug:
• busulfan

• carboplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• melphalan

• vincristine sulfate

Procedure:
• autologous bone marrow transplantation

• conventional surgery

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
Austria	St. Anna Children's Hospital	Vienna
Belgium	Universitair Ziekenhuis Gent	Ghent
Denmark	Rigshospitalet	Copenhagen
France	Centre Hospitalier Regional de Purpan	Toulouse
Italy	Istituto Giannina Gaslini	Genoa
Norway	Rikshospitalet University Hospital	Oslo
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.	Lisboa
Spain	Hospital Universitario LA FE	Valencia
Sweden	Ostra Sjukhuset	Gothenburg
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Bristol Royal Hospital for Children	Bristol	England

Sponsors (1)

Lead Sponsor	Collaborator
European Infant Neuroblastoma Study Group - 1999

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Italy,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Canete A, Gerrard M, Rubie H, Castel V, Di Cataldo A, Munzer C, Ladenstein R, Brichard B, Bermúdez JD, Couturier J, de Bernardi B, Pearson AJ, Michon J. Poor survival for infants with MYCN-amplified metastatic neuroblastoma despite intensified treatment: — View Citation