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Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00588523
Recruitment Status : Active, not recruiting
First Posted : January 8, 2008
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
University of Calgary
Northwestern University
Northwestern Memorial Hospital
Massachusetts General Hospital
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

December 22, 2007
January 8, 2008
February 26, 2018
September 2002
September 2019   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00588523 on ClinicalTrials.gov Archive Site
To determine the neurological and systemic toxicities of such treatment. [ Time Frame: conclusion of study ]
Same as current
Not Provided
Not Provided
 
Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • CNS Cancer
  • CNS BRAIN
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
Experimental: 1
temozolomide followed by high dose busulfan and thiotepa
Intervention: Drug: temozolomide followed by high dose busulfan and thiotepa
Thomas AA, Abrey LE, Terziev R, Raizer J, Martinez NL, Forsyth P, Paleologos N, Matasar M, Sauter CS, Moskowitz C, Nimer SD, DeAngelis LM, Kaley T, Grimm S, Louis DN, Cairncross JG, Panageas KS, Briggs S, Faivre G, Mohile NA, Mehta J, Jonsson P, Chakravarty D, Gao J, Schultz N, Brennan CW, Huse JT, Omuro A. Multicenter phase II study of temozolomide and myeloablative chemotherapy with autologous stem cell transplant for newly diagnosed anaplastic oligodendroglioma. Neuro Oncol. 2017 Oct 1;19(10):1380-1390. doi: 10.1093/neuonc/nox086.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Same as current
September 2019
September 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00588523
02-089
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • University of Calgary
  • Northwestern University
  • Northwestern Memorial Hospital
  • Massachusetts General Hospital
  • Schering-Plough
Principal Investigator: Thomas Kaley, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP