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

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

MedlinePlus related topics:

Cancer Neuroblastoma

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride Ifosfamide Cyclophosphamide Carboplatin Filgrastim Etoposide Cisplatin Melphalan Vincristine sulfate Vincristine Thiotepa Isotretinoin Sargramostim Granulocyte-macrophage colony-stimulating factor Etoposide phosphate Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

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

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:	Stephen A. Grupp, MD, PhD	Children's Hospital of Philadelphia

More 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
First Received:	June 6, 2001
Last Updated:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00017368
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

regional neuroblastoma

disseminated neuroblastoma

localized unresectable neuroblastoma

stage 4S neuroblastoma

Study placed in the following topic categories:

Melphalan

Neuroectodermal Tumors, Primitive

Vincristine

Carboplatin

Cyclophosphamide

Etoposide phosphate

Neuroblastoma

Doxorubicin

Thiotepa

Neuroectodermal Tumors

Ifosfamide

Cisplatin

Neoplasms, Germ Cell and Embryonal

Isotretinoin

Neuroepithelioma

Etoposide

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Glandular and Epithelial

Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms by Histologic Type

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Mitosis Modulators

Neoplasms, Nerve Tissue

Physiological Effects of Drugs

Antimitotic Agents

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Therapeutic Uses

Tubulin Modulators

Myeloablative Agonists

Antineoplastic Agents, Alkylating

Neoplasms, Neuroepithelial

Antirheumatic Agents

Dermatologic Agents

Antineoplastic Agents, Phytogenic

Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008

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