Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00653068
First received: April 3, 2008
Last updated: November 3, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.
PURPOSE: This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: etoposide phosphate Drug: methotrexate Drug: thiotepa Drug: vincristine sulfate Genetic: mutation analysis Other: immunohistochemistry staining method Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: 3-dimensional conformal radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Cyclophosphamide
Thiotepa
Methotrexate
Vincristine sulfate
Methotrexate sodium
Cisplatin
Etoposide
Carboplatin
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival [ Designated as safety issue: No ]
- Toxic death, defined as death primarily attributable to complications of treatment [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Toxicity and safety [ Designated as safety issue: Yes ]
- Survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of CNS atypical teratoid/rhabdoid tumor (AT/RT) or tumors that have a mutation of the INI1 gene (even if the tumor does not have the usual histologic characteristics of AT/RT)
- Patients with extraneural metastasis (M4) or renal rhabdoid tumors are not eligible
- Patients with MRI evidence of spinal disease are eligible
- Must have undergone definitive surgery in the past 31 days
Cranial MRI (with and without gadolinium) must be done pre-operatively
- Post-operatively, cranial MRI (with and without gadolinium) must be done, preferably within 48 hours of surgery or 10-28 days after surgery
- Entire spinal MRI must be obtained either pre-operatively (with gadolinium) or post-operatively (10- 28 days after surgery), prior to study enrollment (with and without gadolinium)
PATIENT CHARACTERISTICS:
- Life expectancy > 8 weeks
- ANC > 1,000/μL
- Platelet count > 100,000/μL (transfusion independent)
- Hemoglobin > 8 g/dL (RBC transfusions allowed)
- Creatinine clearance (minimum of 12-24 hour urine collection) or radioisotope GFR ≥ 60 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- AST and ALT < 2 times ULN for age
- Shortening fraction of ≥ 27% by echocardiogram OR ejection fraction of ≥ 47% by radionuclide angiogram
- No evidence of dyspnea at rest
- Pulse oximetry > 94% on room air
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
No prior radiotherapy or chemotherapy except for the following:
- Patients enrolled on protocol ACNS0334 whose tumors demonstrate the INI1 gene mutation are eligible to transfer to this study even if they have received one course of induction therapy (these patients must be re-consented to treatment and restaged)
- Prior corticosteroids allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653068
Show 87 Study Locations
Show 87 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Principal Investigator: | Alyssa T. Reddy, MD | Children's Hospital of Alabama at University of Alabama at Birmingham |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00653068 History of Changes |
| Other Study ID Numbers: | CDR0000592812, COG-ACNS0333 |
| Study First Received: | April 3, 2008 |
| Last Updated: | November 3, 2012 |
| Health Authority: | Unspecified |
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 Etoposide phosphate Cisplatin Cyclophosphamide Etoposide Methotrexate Thiotepa Vincristine |
Carboplatin Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013