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Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, December 2008
First Received: December 22, 2007   Last Updated: December 9, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Albany Medical College
Columbia University
Norris Comprehensive Cancer Center
Northwestern Memorial Hospital
University of Pittsburgh
Evanston NorthShore University HealthSystem
University of Calgary
University of Southern California
University of Wisconsin, Madison
University of Toronto
University of Rochester
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588523
  Purpose

The purpose of this study is to see how effective treatment of high doses of chemotherapy is for your tumor. We will also be looking at the side effects and risks of this treatment. You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy tumor cells, but it can also destroy normal bone marrow cells.

These cells produce white blood cells (which fight infection), red blood cells (which carry oxygen) and platelets (which allow your blood to clot). With too few of these cells there is a serious risk of infection and bleeding. Therefore, before treatment begins, we will collect some of your own blood cells, called peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs are thawed and given back to you. These healthy PBPCs will replace the blood cells that the high dose chemotherapy destroys and allow your bone marrow to recover and produce blood cells. In a prior study we treated 69 patients in a similar way. More than half were able to avoid or delay brain radiation. This new study will use a different high dose chemotherapy regimen.


Condition Intervention Phase
CNS Cancer
CNS BRAIN
Drug: temozolomide followed by high dose busulfan and thiotepa
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Thiotepa Busulfan Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the duration of disease control of newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with dose-intensive chemotherapy requiring hematopoietic stem cell support. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the neurological and systemic toxicities of such treatment. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2002
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
temozolomide followed by high dose busulfan and thiotepa
Drug: temozolomide followed by high dose busulfan and thiotepa
Temozolomide 200mg/m2 PO Days 1-5 recycled every 28 days Day minus -8 thiotepa 250 mg/m2 intravenously Day minus -7 thiotepa 250 mg/m2 intravenously Day minus -6 thiotepa 250 mg/m2 intravenously Day minus -5 busulfan 3.2 mg/kg intravenously over two hours Day minus -4 busulfan 3.2 mg/kg intravenously over two hours Day minus -3 busulfan 3.2 mg/kg intravenously over two hours Day minus -2 rest Day minus -1 rest Day 0 peripheral blood stem cell or bone marrow reinfusion

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic evidence of an anaplastic oligodendroglioma. For this study, World Health Organization classification criteria will be used. Central pathology review must take place prior to high-dose therapy but need not occur prior to study entry and induction therapy.
  • Pathologic evidence of an anaplastic mixed glioma (i.e. oligoastrocytoma). Again, histopathologic diagnosis will be made using World Health Organization classification criteria. To qualify as a mixed tumor there must be a minimum of 25% oligodendroglial element. Central pathology review must take place prior to high-dose therapy but need not occur in advance of enrollment or induction therapy.
  • The diagnostic surgical procedure may have been a complete resection, partial resection, or biopsy.
  • Karnofsky performance status > or equal to 60.
  • Granulocyte count > or equal to 1.5 X 109/L.
  • Platelet count > or equal to 100 X 109/L
  • SGOT < than or equal to 2X upper limit of normal.
  • Serum creatinine < than or equal to 1.5X upper limit of normal
  • Bilirubin < than or equal to 1.5X upper limit of normal
  • All patients must sign written informed consent.

Exclusion Criteria:

  • Systemic or leptomeningeal metastases (excluding contiguous leptomeninges)
  • Prior cranial radiotherapy or systemic chemotherapy
  • Other concurrent malignancy (with the exception of cervical carcinoma in situ or basal cell carcinoma of the skin) or serious illness if this would interfere with the prescribed treatment.
  • Pregnant or lactating women
  • Refusal to use effective contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588523

Contacts
Contact: Lauren Abrey, MD 212-639-5122 abreyl@mskcc.org
Contact: Lisa De Angelis, MD 212-639-7997 deangell@mskcc.org

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Lauren Abrey, MD     212-639-5122     abreyl@mskcc.org    
Principal Investigator: Lauren Abrey, MD            
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lauren Abrey, MD     212-639-5122     abreyl@mskcc.org    
Contact: Lisa De Angelis, MD     212-639-7123     deangell@mskcc.org    
Principal Investigator: Lauren Abrey, MD            
Memorial Sloan-Kettering Cancer Center Recruiting
Commack, New York, United States
Contact: Lauren Abrey, MD     212-639-5122     abreyl@mskcc.org    
Principal Investigator: Lauren Abrey, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Albany Medical College
Columbia University
Norris Comprehensive Cancer Center
Northwestern Memorial Hospital
University of Pittsburgh
Evanston NorthShore University HealthSystem
University of Calgary
University of Southern California
University of Wisconsin, Madison
University of Toronto
University of Rochester
Investigators
Principal Investigator: Lauren Abrey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Lauren Abrey, MD )
Study ID Numbers: 02-089
Study First Received: December 22, 2007
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00588523     History of Changes
Health Authority: United States: Federal Government;   United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Brain
CNS
TEMOZOLOMIDE
Busulfan
Thiotepa

Study placed in the following topic categories:
Immunologic Factors
Central Nervous System Neoplasms
Temozolomide
Immunosuppressive Agents
Thiotepa
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Busulfan
Neuroepithelioma
Oligodendroglioma
Glioma
Antineoplastic Agents, Alkylating
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Temozolomide
Immunosuppressive Agents
Pharmacologic Actions
Thiotepa
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Busulfan
Myeloablative Agonists
Oligodendroglioma
Antineoplastic Agents, Alkylating
Glioma
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009