Text Size

A Dose Per Fraction Escalation Trial of Hypofractionated IMRT With Temozomide for Newly Diagnosed Glioblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00792012
First received: November 13, 2008
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of the study is to find out the highest dose per fraction of hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) that can be safely given with temozolomide chemotherapy.


Condition Intervention Phase
Glioblastoma Multiforme
 Radiation: Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT)
Drug: Temozomide
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Per Fraction Escalation Study of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) Chemotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • To identify the maximum dose per fraction of IMRT a patient can tolerate while keeping the total radiation dose at 60 Gy, provided concurrently with daily oral temozolomide chemotherapy [ Time Frame: TBD ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival. To monitor the level of some of the known and unknown cytokines or proteins before and after Hypo-IMRT & correlate it with the incidence of acute and late neurotoxicity. Quality of life assessment before & after treatment. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: November 2005
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Newly diagnosed Glioblastoma Multiforme Patients
Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining with Temozolomide (TMZ) Chemotherapy
 Radiation: Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT)
Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining with Temozolomide (TMZ) Chemotherapy
Drug: Temozomide
Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining with Temozolomide (TMZ) Chemotherapy

Detailed Description:

Hypo-IMRT is given in fewer treatments than conventional radiation therapy. This will be a dose per fraction escalation study. A dose per fraction escalation study means that successive groups of patients will receive higher doses per fraction of radiation while keeping the total dose of radiation the same (60 Gy, Gy is a radiation unit). The radiation dose per fraction will be increased and the numbers of radiation treatments will be decreased until a fraction dose is reached at which there are unacceptable side effect compared with possible benefit. Which group you are in will depend on what stage the study has reached at the time you decide to participate.

This research is being done because with current standard radiation therapy (A total dose of 60 Gy given 2 Gy a day over 6 weeks.) the outcome is very poor. New and more effective radiation therapy methods are desperately needed for the patients like you with GBM.

In this study, radiation therapy is given together with chemotherapy of Temozolomide.

This study is also designed to monitor the level of some of the known cytokines (specific proteins in the blood) before and after radiation, and in meantime to screen unknown proteins in patients' blood before and after radiation therapy. Hopefully, this will provide us with some clues for future study of monitoring radiation damage, and possibly new therapeutic approach for patients like you with GBM.

  Eligibility

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

Inclusion Criteria:

  • Histopathologically confirmed WHO grade IV astrocytoma (GBM), tumor can be supra- or infra-tentorial in location but not located in the brain stem.
  • Solitary or multifocal tumor.
  • Tumor can be biopsied or resected, either totally or sub-totally.
  • A pre-radiation therapy brain MRI is mandatory. Patients with contraindications for MRI scanning are ineligible for this study.
  • Surgical cavity or surgical cavity + T1 enhancing residual tumor ≤ 6 cm in the largest diameter on the pre-radiation therapy MRI. In the case of multifocal tumor, the combined largest diameter of T1 enhancing tumor + surgical cavity ≤ 6 cm.
  • Placement of bis-chloronitrosourea (BCNU) wafers at the time of surgery is allowed.
  • Age > 18 years at time of registration.
  • Estimated survival of at least 3 months.
  • Zubrod Performance Scale of 0-2 (Karnofsky performance scale ≥ 60).
  • Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/ul; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value.
  • Patients cannot be treated on any other clinical protocols within 30 days prior to study entry or during participation in the study.
  • Patients must sign study-specific informed consent form prior to registration.
  • Men and women and members of all ethnic groups are eligible for this trial.
  • No active connective tissue disorders, such as active lupus or scleroderma.
  • Radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy

Exclusion Criteria:

  • prior temozolomide chemotherapy.
  • prior brain irradiation.
  • evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
  • Acquired Immune Deficiency (HIV (+)/AIDS)
  • pregnant women or breast feeding women. Women of childbearing potential must practice medically approved contraceptive precautions. Men should be counseled and agreeable to follow acceptable birth control methods.
  • concurrent active malignancy at other sites.
  • frequent vomiting of medical condition which could interfere with oral medication intake (e.g. partial bowel obstruction).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792012

Locations
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Changhu Chen, M.D University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00792012     History of Changes
Other Study ID Numbers: 05-0562.cc
Study First Received: November 13, 2008
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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 May 22, 2013