Temozolomide in Treating Patients With Anaplastic Oligodendroglioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00003465
First received: November 1, 1999
Last updated: June 19, 2013
Last verified: October 2009
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with anaplastic oligodendroglioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults With Newly Diagnosed, Progressive or Recurrent Primary Malignant Anaplastic Oligodendroglioma With Temodal

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 60
Study Start Date: March 1998
Study Completion Date: February 2001
Detailed Description:

OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed, progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this drug in this patient population.

OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with progressive or recurrent disease (at baseline) continue treatment in the absence of disease progression or unacceptable toxicity. Patients with newly diagnosed disease continue treatment for a maximum of 4 courses before radiotherapy in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive an additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study treatment.) Patients are followed every 8 weeks for 2 years.

PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least 1.5 cm2 by MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Neurologically stable No nonmalignant systemic disease No acute infection treated with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy: No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No other concurrent investigational drugs

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003465

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Henry S. Friedman, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Henry Friedman, MD, Duke UMC
ClinicalTrials.gov Identifier: NCT00003465     History of Changes
Other Study ID Numbers: 1534, DUMC-1534-00-8R3, DUMC-1372-97-9, DUMC-1403-98-9R1, DUMC-1550-99-9R2, DUMC-97104, NCI-G98-1468, CDR0000066501
Study First Received: November 1, 1999
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
recurrent adult brain tumor
adult anaplastic oligodendroglioma

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

ClinicalTrials.gov processed this record on April 17, 2014