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

Sponsors and Collaborators:	Dana-Farber Cancer Institute 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	Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dactinomycin Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: leucovorin calcium Drug: methotrexate Drug: temozolomide Drug: therapeutic hydrocortisone Drug: vincristine sulfate Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Filgrastim Cytarabine Cytarabine hydrochloride Etoposide Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Vincristine sulfate Vincristine Cisplatin Temozolomide Etoposide phosphate Calcium gluconate Dexrazoxane Dexrazoxane hydrochloride ICRF 159 Razoxane Dactinomycin

U.S. FDA Resources

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

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

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

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:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00084838
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

childhood atypical teratoid/rhabdoid tumor

Study placed in the following topic categories:

Hydrocortisone
Rhabdoid Tumor
Cortisol succinate
Leucovorin
Vincristine
Central Nervous System Neoplasms
Cyclophosphamide
Etoposide phosphate
Temozolomide
Doxorubicin
Razoxane

Rhabdoid tumor
Folic Acid
Calcium, Dietary
Cisplatin
Dactinomycin
Methotrexate
Hydrocortisone acetate
Etoposide
Nervous System Neoplasms
Cytarabine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Neoplasms by Site
Vitamins
Therapeutic Uses
Abortifacient Agents

Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Neoplasms by Histologic Type
Growth Substances
Mitosis Modulators
Nervous System Diseases
Enzyme Inhibitors
Antimitotic Agents
Cardiovascular Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents

ClinicalTrials.gov processed this record on January 16, 2009