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
Recruitment status was Active, not recruiting
Sponsor:
Dana-Farber Cancer Institute
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
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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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Hydrocortisone acetate
Cyclophosphamide
Hydrocortisone
Dactinomycin
Methotrexate
Hydrocortisone sodium succinate
Cytarabine
Hydrocortisone cypionate
Leucovorin calcium
Vincristine sulfate
Hydrocortisone butyrate
Methotrexate sodium
Cisplatin
Doxorubicin
Dexrazoxane
Doxorubicin hydrochloride
Etoposide
Hydrocortisone valerate
Levoleucovorin
Hydrocortisone probutate
Temozolomide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Dexrazoxane hydrochloride
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
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 May 23, 2013