Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

October 25, 2023 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Cancer Center
    • New York
      • Commack, New York, United States
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progession Free Survival
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Evaluated for Toxicities
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Massachusetts General Hospital
Northwestern University
University of Calgary
Schering-Plough
Northwestern Memorial Hospital

Investigators

  • Principal Investigator: Thomas Kaley, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Actual)

February 2, 2023

Study Completion (Actual)

February 2, 2023

Study Registration Dates

First Submitted

December 22, 2007

First Submitted That Met QC Criteria

December 22, 2007

First Posted (Estimated)

January 8, 2008

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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