Know Cancer

or
forgot password

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


Phase 2
N/A
N/A
Open (Enrolling)
Both
CNS Cancer, CNS BRAIN

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Antonio Omuro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

02-089

NCT ID:

NCT00588523

Start Date:

September 2002

Completion Date:

September 2013

Related Keywords:

  • CNS Cancer
  • CNS BRAIN
  • Brain
  • CNS
  • TEMOZOLOMIDE
  • Busulfan
  • Thiotepa
  • Oligodendroglioma
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey