Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy and Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Oligodendroglioma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003101
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with autologous bone marrow transplantation or peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bone marrow transplantation or peripheral stem cell transplantation in treating patients who have oligodendroglioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: filgrastim
Drug: busulfan
Drug: lomustine
Drug: procarbazine hydrochloride
Drug: thiotepa
Drug: vincristine sulfate
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase II

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Estimated Enrollment: 60
Study Start Date: August 1997
Detailed Description:

OBJECTIVES:

  • Determine the duration of response in patients with newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with intensive chemotherapy supported by autologous transplantation.
  • Determine the neurological and systemic toxic effects of this regimen in these patients.
  • Determine the relationship of 1p loss of heterozygosity on radiographic response, progression-free survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Mobilization and stem cell harvest: Patients receive filgrastim (G-CSF) subcutaneously daily for up to 7 days followed by peripheral blood stem cell (PBSC) or bone marrow (BM) harvest.
  • Induction therapy: All patients then receive induction therapy (PCV) comprising of oral lomustine on day 1, vincristine IV on days 8 and 29, and oral procarbazine on days 8-21. Treatment repeats every 42 days in the absence of progressive disease or unacceptable toxicity. Patients with prior complete resections receive 3 courses of PCV then proceed to high-dose chemotherapy and transplantation as described below, provided tumor has not recurred. Patients with prior partial resections or biopsies receive 2 courses of PCV and are assessed for response; those who achieve complete response (CR) or major partial response (PR) receive 1 more course of PCV.

Patients who achieve partial response or have stable disease receive 2 more courses of PCV and are reassessed.

  • High-dose chemotherapy and transplantation: Patients who achieve CR or PR receive thiotepa IV on days -8 to

    • 6 and busulfan IV over 2 hours on day -5 to -3. Patients undergo autologous BM or PBSC transplantation on day 0. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 3-5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven anaplastic oligodendroglioma OR
  • Histologically proven anaplastic mixed glioma (oligoastrocytoma) provided there is an unequivocal and substantial (at least 25%) oligodendroglial element
  • No systemic or leptomeningeal metastases (excluding contiguous leptomeninges)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
  • SGOT no greater than 2 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • LVEF at least 50%

Pulmonary

  • DLCO at least 50% of predicted

Other

  • No other serious illness that would preclude study therapy
  • No other concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior systemic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior cranial radiotherapy

Surgery

  • Prior complete or partial resection, open biopsy, or stereotactic biopsy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003101

Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Illinois
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Lisa M. DeAngelis, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065833, MSKCC-97077, NCI-G97-1335
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003101     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult oligodendroglioma
adult anaplastic oligodendroglioma

Study placed in the following topic categories:
Lomustine
Vincristine
Antimitotic Agents
Central Nervous System Neoplasms
Thiotepa
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Busulfan
Tubulin Modulators
Neuroepithelioma
Oligodendroglioma
Glioma
Procarbazine
Antineoplastic Agents, Phytogenic
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Nervous System Diseases
Neoplasms, Nerve Tissue
Vincristine
Antimitotic Agents
Central Nervous System Neoplasms
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Tubulin Modulators
Oligodendroglioma
Procarbazine
Glioma
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009