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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00084838
First received: June 10, 2004
Last updated: April 21, 2009
Last verified: January 2008
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00084838     History of Changes
Other 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
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood atypical teratoid/rhabdoid tumor

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Rhabdoid Tumor
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Dactinomycin
Doxorubicin
Methotrexate
Cytarabine
Temozolomide
Cisplatin
Cyclophosphamide
Etoposide
Razoxane
Vincristine
Lenograstim
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Leucovorin
Levoleucovorin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014