Intrathecal and Systemic Chemotherapy Combined With Radiation Therapy in Treating Young Patients With Newly Diagnosed Central Nervous System Atypical Teratoid/Rhabdoid Tumors - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00084838

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Biological: dactinomycin Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: temozolomide Drug: therapeutic hydrocortisone Drug: vincristine sulfate Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Single-Arm, Open Label Limited-Institutional Phase II Study of Multi-Agent Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children < or = 18 Years With Newly Diagnosed Central Nervous System Atypical Teratoid/Rhabdoid Tumor

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Hydrocortisone acetate Cyclophosphamide Hydrocortisone Dactinomycin Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Cisplatin Razoxane Doxorubicin Dexrazoxane Doxorubicin hydrochloride Etoposide Citrovorum factor Proctofoam-HC Hydrocortisone hemisuccinate Temozolomide Hydrocortamate Myocet Etoposide phosphate Filgrastim Dexrazoxane hydrochloride Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Leucovorin Calcium Vincristine sulfate Cortisol succinate Cortisol 21-phosphate Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Primary Outcome Measures:

Efficacy as assessed by improvement in median survival from 50-79% in comparison to historical outcomes from prior trials at 7 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity and tolerability as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
Chemosensitivity as measured by radiographic response [ Designated as safety issue: No ]
Predictive value of tumor biology studies as assessed by histopathology and INI-1 gene expression from pathology obtained at time of diagnosis [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	February 2003
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary intracranial CNS atypical teratoid/rhabdoid tumor OR
Tumor tissue that possesses the INI 1 gene mutation
No metastases that disseminate outside the CNS by abdominal and chest CT scans, kidney imaging, and bone marrow biopsy
- No obstruction of cerebrospinal fluid (CSF) flow by CSF flow study
Definitive surgical resection of tumor within the past 35 days

PATIENT CHARACTERISTICS:

Age

18 and under

Performance status

Karnofsky 50-100% OR
Lansky 50-100%

Life expectancy

Not specified

Hematopoietic

Hemoglobin > 10 g/dL
Absolute neutrophil count > 1,000/mm^3
Platelet count > 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 mg/dL
SGPT < 10 times normal

Renal

Creatinine ≤ 1.5 times normal

Other

Willing to have placement of central venous access line

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Prior steroids allowed

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics

Other

No other prior or concurrent investigational agents
Concurrent anticonvulsant agents allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084838

Locations

United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5826
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States, 30342
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Dana-Farber Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Mark W. Kieran, MD, PhD

Dana-Farber Cancer Institute

More Information

Additional Information:

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

Publications:

Chi SN, Zimmerman MA, Yao X, Cohen KJ, Burger P, Biegel JA, Rorke-Adams LB, Fisher MJ, Janss A, Mazewski C, Goldman S, Manley PE, Bowers DC, Bendel A, Rubin J, Turner CD, Marcus KJ, Goumnerova L, Ullrich NJ, Kieran MW. Intensive multimodality treatment for children with newly diagnosed CNS atypical teratoid rhabdoid tumor. J Clin Oncol. 2009 Jan 20;27(3):385-9. Epub 2008 Dec 8.

Study ID Numbers:	CDR0000365641, DFCI-02294, UTSMC-0403210, JHOC-JHM-IRB5, SUMC-78899, CHP-2003-2-3169, CCF-IRB-6140, CHCM-0302-004
Study First Received:	June 10, 2004
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00084838 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

childhood atypical teratoid/rhabdoid tumor

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Neoplasms
Razoxane
Neoplasms by Site
Dactinomycin
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Etoposide

Nervous System Neoplasms
Nucleic Acid Synthesis Inhibitors
Nervous System Diseases
Vincristine
Abortifacient Agents, Nonsteroidal
Temozolomide
Doxorubicin
Neoplasms
Chelating Agents
Hydrocortisone acetate
Antineoplastic Agents, Phytogenic
Neoplasms, Complex and Mixed
Antimetabolites
Rhabdoid Tumor
Immunologic Factors

ClinicalTrials.gov processed this record on November 05, 2009