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Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

Primary Purpose

CNS Cancer, CNS BRAIN

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

temozolomide followed by high dose busulfan and thiotepa

About this trial

This is an interventional treatment trial for CNS Cancer focused on measuring Brain, CNS, TEMOZOLOMIDE, Busulfan, Thiotepa

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

temozolomide followed by high dose busulfan and thiotepa

Outcomes

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.

Secondary Outcome Measures

To determine the neurological and systemic toxicities of such treatment.

Full Information

NCT ID

NCT00588523

First Posted

December 22, 2007

Last Updated

February 7, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00588523

Brief Title

Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

Official Title

A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

September 2002 (Actual)

Primary Completion Date

February 2, 2023 (Actual)

Study Completion Date

February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CNS Cancer, CNS BRAIN

Keywords

Brain, CNS, TEMOZOLOMIDE, Busulfan, Thiotepa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

temozolomide followed by high dose busulfan and thiotepa

Intervention Type

Drug

Intervention Name(s)

temozolomide followed by high dose busulfan and thiotepa

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To determine the neurological and systemic toxicities of such treatment.

Time Frame

conclusion of study

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Kaley, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

Basking Ridge

State/Province

New Jersey

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

Commack

State/Province

New York

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28472509

Citation

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.

Results Reference

derived

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

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