Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT00588523
First received: December 22, 2007
Last updated: February 13, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Calgary
Northwestern University
Northwestern Memorial Hospital
Massachusetts General Hospital
Schering-Plough
Investigators
Principal Investigator: Antonio Omuro, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588523     History of Changes
Other Study ID Numbers: 02-089
Study First Received: December 22, 2007
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014