Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00017368

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral stem cell 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 followed by peripheral stem cell transplantation in treating children who have newly diagnosed neuroblastoma.

Condition	Intervention	Phase
Neuroblastoma	Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: etoposide phosphate Drug: ifosfamide Drug: isotretinoin Drug: melphalan Drug: thiotepa Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma

Resource links provided by NLM:

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

Study Start Date:

April 2001

Show Detailed Description

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed high-risk neuroblastoma
- Histologically proven AND/OR
- Bone marrow specimen showing clumps of tumor cells accompanied by elevated urinary catecholamines
- Age 1-30:
  - Must meet one of the following INSS staging criteria:
    - Stage IV regardless of biologic factors
    - Stage IIa/IIb with MYCN oncogene amplification (greater than 10) and unfavorable pathology
    - Stage III with MYCN oncogene amplification (greater than 10) or unfavorable pathology
    - Initially stage I, II, or IVS, that has progressed without interval chemotherapy
- Under age 1:
  - INSS stage III, IV, or IVS with MYCN amplification (greater than 10)
Must enter neuroblastoma biology study COG-ANBL00B1 within 2 weeks of diagnosis and before entry on this study

PATIENT CHARACTERISTICS:

Age:

30 and under at original diagnosis

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics
No more than 1 prior course of chemotherapy on the intergroup low- or intermediate-risk neuroblastoma studies prior to determination of MYCN status and Shimada histology

Endocrine therapy:

Not specified

Radiotherapy:

Prior emergent radiotherapy to sites of function- or life-threatening neuroblastoma allowed

Surgery:

Not specified

Other:

No other prior systemic therapy for neuroblastoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017368

Locations

United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish RiteCampus
Atlanta, Georgia, United States, 30342
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Floating Hospital for Children
Boston, Massachusetts, United States, 02111
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Stephan A. Grupp, MD, PhD

Children's Hospital of Philadelphia

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Marcus KJ, Shamberger R, Litman H, von Allmen D, Grupp SA, Nancarrow CM, Goldwein J, Grier HE, Diller L. Primary tumor control in patients with stage 3/4 unfavorable neuroblastoma treated with tandem double autologous stem cell transplants. J Pediatr Hematol Oncol. 2003 Dec;25(12):934-40.

Kletzel M, Katzenstein HM, Haut PR, Yu AL, Morgan E, Reynolds M, Geissler G, Marymount MH, Liu D, Kalapurakal JA, Shore RM, Bardo DM, Schmoldt J, Rademaker AW, Cohn SL. Treatment of high-risk neuroblastoma with triple-tandem high-dose therapy and stem-cell rescue: results of the Chicago Pilot II Study. J Clin Oncol. 2002 May 1;20(9):2284-92.

Donovan J, Temel J, Zuckerman A, Gribben J, Fang J, Pierson G, Ross A, Diller L, Grupp SA. CD34 selection as a stem cell purging strategy for neuroblastoma: preclinical and clinical studies. Med Pediatr Oncol. 2000 Dec;35(6):677-82.

Grupp SA, Stern JW, Bunin N, Nancarrow C, Adams R, Gorlin JB, Griffin G, Diller L. Rapid-sequence tandem transplant for children with high-risk neuroblastoma. Med Pediatr Oncol. 2000 Dec;35(6):696-700.

Grupp SA, Stern JW, Bunin N, Nancarrow C, Ross AA, Mogul M, Adams R, Grier HE, Gorlin JB, Shamberger R, Marcus K, Neuberg D, Weinstein HJ, Diller L. Tandem high-dose therapy in rapid sequence for children with high-risk neuroblastoma. J Clin Oncol. 2000 Jul;18(13):2567-75.

Study ID Numbers:	CDR0000068681, COG-ANBL00P1
Study First Received:	June 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00017368 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

regional neuroblastoma
disseminated neuroblastoma
localized unresectable neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:

Melphalan
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Cyclophosphamide
Antibiotics, Antineoplastic
Etoposide phosphate
Neuroblastoma
Cisplatin
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Isotretinoin

Dermatologic Agents
Alkylating Agents
Etoposide
Neoplasms by Histologic Type
Mitosis Modulators
Vincristine
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Thiotepa
Neuroectodermal Tumors
Neoplasms
Ifosfamide

ClinicalTrials.gov processed this record on November 09, 2009