Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00003464
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 adults with newly diagnosed primary malignant glioblastoma multiforme.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 50
Study Start Date: September 1997
Study Completion Date: August 2003
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.
  • Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.
  • Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.

OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: This study will accrue 50 patients.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy
  • At least 1 bidimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Greater than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT and 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:

  • Must be neurologically stable
  • No systemic disease
  • No acute infection requiring intravenous antibiotics
  • No frequent vomiting
  • No other medical condition that would interfere with oral medication intake such as partial bowel obstruction
  • No prior or concurrent malignancies except:

    • Surgically cured carcinoma in situ of the cervix
    • Basal or squamous cell carcinoma of the skin
  • HIV negative
  • No AIDS-related illness
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy
  • No concurrent biologic therapy (growth factors or erythropoietin)

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study)

Radiotherapy:

  • No prior radiation therapy
  • No prior interstitial brachytherapy
  • No prior radiosurgery to the brain
  • Not requiring immediate radiation therapy
  • No concurrent radiotherapy

Surgery:

  • Recovered from any effects of prior surgery
  • At least 2 weeks since prior surgical resection

Other:

  • No other concurrent investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003464

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: NCT00003464     History of Changes
Other Study ID Numbers: 1171, DUMC-1171-01-6R4, DUMC-1016-97-7, DUMC-1056-98-7R1, DUMC-1058-98-7R1, DUMC-1171-00-6R3, DUMC-1231-99-7R2, DUMC-97081, NCI-G98-1465, CDR0000066498
Study First Received: November 1, 1999
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

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

ClinicalTrials.gov processed this record on October 23, 2014