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

NCT00792012 | Completed Phase 1 DMC

• 1 other identifier: 05-0562.cc
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• 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

  To determine the frequency of patients developing \>= grade 3 acute and delayed toxicities attributable to radiotherapy. Acute radiotherapy toxicities are defined as those toxicities which occur during and within 30 days from the completion of radiotherapy and delayed toxicity are those developed at least 30 days after the last dose of radiation.

  Up to 60 days

Secondary Outcomes (1)

• Progression-free survival

  Until disease progression

Study Arms (1)

Glioblastoma Multiforme Patients

EXPERIMENTAL

Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining with Temozolomide (TMZ) Chemotherapy

Radiation: Hypofractionated Intensity-Modulated Radiation Therapy; Drug: Temozolomide

Interventions

Hypofractionated Intensity-Modulated Radiation Therapy RADIATION

All patients will receive one fraction of radiation therapy a day, 5 days a week, Monday through Friday. Radiation fraction size and number of fractions depend on dose fraction level the patient is assigned to.

Glioblastoma Multiforme Patients

Temozolomide DRUG

Temozolomide will be administered orally, once a day starting on the first day of radiation, for 28 consecutive days during radiation, and after radiation for those patients completing radiation in less than 28 days.

Also known as: Temodar

Glioblastoma Multiforme Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 must sign study-specific informed consent form prior to registration.
• Men and women and members of all ethnic groups are eligible for this trial.
• Radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy

You may not qualify if:

• Patients with contraindications for MRI scanning.
• 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)
• Patients being treated on any other clinical protocols within 30 days prior to study entry or during participation in the study.
• 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.
• Active connective tissue disorders, such as active lupus or scleroderma.
• Concurrent active malignancy at other sites.
• Frequent vomiting of medical condition which could interfere with oral medication intake (e.g. partial bowel obstruction).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Reddy K, Damek D, Gaspar LE, Ney D, Waziri A, Lillehei K, Stuhr K, Kavanagh BD, Chen C. Phase II trial of hypofractionated IMRT with temozolomide for patients with newly diagnosed glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):655-60. doi: 10.1016/j.ijrobp.2012.01.035. Epub 2012 Apr 5.

  PMID: 22483738 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Douglas Ney, M.D

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: November 1, 2005
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)