Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Ohio State University Comprehensive Cancer Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00841555
First received: February 10, 2009
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.


Condition Intervention Phase
Glioblastoma Multiforme/Anaplastic Astrocytoma
Drug: temozolomide
Radiation: radiation therapy
Radiation: stereotactic radiotherapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose of temozolomide [ Time Frame: 2009-present ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to neuroradiological evidence of tumor recurrence or progression [ Time Frame: 2009-present ] [ Designated as safety issue: No ]
  • Survival time [ Time Frame: 2009-present ] [ Designated as safety issue: No ]
  • Time spent in a Karnofsky performance status of 60-100% [ Time Frame: 2009-present ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: February 2009
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: temozolomide

    Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.

    Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment

    Other Names:
    • Temodar
    • Temodal
    Radiation: radiation therapy
    Radiation therapy will be started up to 8 weeks after surgery/biopsy. Patients will receive focal radiation therapy to an area including the Gross Target Volume (GTV) defined as the contrast enhancing area and/or the surgical cavity plus the surrounding edema + 2 cm margin. GTV will be determined with a contrast enhanced pre RT MRI/CT scan of the brain.
    Other Name: radiotherapy
    Radiation: stereotactic radiotherapy
    Patients will receive intensity modulated conformal stereotactic radiotherapy at a dose of 3.5 Gy/fraction over 3 consecutive weeks in 5 fractions/ week, using the Peacock system with the Talon immobilization/localization device. Patients will be seen by one of the radiation oncology co-investigators prior to talon anchor placement.
    Other Name: external beam radiation
Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of temozolomide when given in combination with hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.

Secondary

  • To determine the time to neuroradiological evidence of tumor recurrence or progression in patients treated with this regimen.
  • To determine the survival time of patients treated with this regimen.
  • To determine the time spent in a Karnofsky performance status of 60-100%.

OUTLINE: This is a dose-escalation study of temozolomide.

Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a week for 3 weeks.

After completion of study treatment, patients are followed at 1 month, 2 months, and 3 months, and then every 3 months thereafter.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed de novo glioblastoma multiforme or anaplastic astrocytoma after biopsy or tumor removal

    • Newly diagnosed disease
  • No tumors located in the brainstem or optic chiasm

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Hemoglobin ≥ 10 g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 mg/dL
  • Creatinine ≤ 1.3 mg/dL
  • AST/ALT ≤ 60 U/L
  • BUN ≤ 24 mg/dL

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy and/or radiotherapy for this cancer
  • No prior radiotherapy to the brain
  • At least 6 weeks since prior chemotherapy
  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: NCT00841555

Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Mario Ammirati, MD 614-293-1967 mario.ammirati@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Mario Ammirati, MD    866-627-7616      
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Mario Ammirati, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00841555     History of Changes
Other Study ID Numbers: OSU-08119, NCI-2011-03149
Study First Received: February 10, 2009
Last Updated: November 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic astrocytoma
adult glioblastoma
GBM/AA

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
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 September 18, 2014