NCT00052208

Brief Summary

This phase I/II trial studies the side effects and best dose of gefitinib when given together with radiation therapy and to see how well it works in treating patients with glioblastoma multiforme. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving gefitinib together with radiation therapy may be an effective treatment for glioblastoma multiforme.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

3.3 years

First QC Date

January 24, 2003

Last Update Submit

October 29, 2020

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult Gliosarcoma

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose of gefitinib defined as the dose at which no patients develop acute grade 5 toxicity and less than 30% of patients developed acute dose limiting toxicity graded by the National Cancer Institute Common Toxicity Criteria v2.0

    Within 90 days from the start of radiotherapy treatment

  • Rate of late toxicities associated with gefitinib and standard cranial radiation, graded according to the NCI CTC v2.0

    Up to 10 years

  • Overall survival, by EGFR status

    Up to 10 years

Secondary Outcomes (1)

  • Progression-free survival

    Up to 10 years

Study Arms (1)

Treatment (gefitinib, radiation therapy)

EXPERIMENTAL

Patients receive gefitinib PO QD for 7 weeks. Beginning 1 week after initiation of gefitinib, patients undergo radiation therapy QD 5 days a week for 6 weeks. Treatment with gefitinib continues for up to 18 months in the absence of disease progression or unacceptable toxicity.

Drug: gefitinibRadiation: radiation therapyOther: laboratory biomarker analysis

Interventions

gefitinibDRUG

Given PO

Also known as: Iressa, ZD 1839
Treatment (gefitinib, radiation therapy)
radiation therapyRADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Treatment (gefitinib, radiation therapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gefitinib, radiation therapy)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histopathologically confirmed glioblastoma multiforme (with areas of necrosis)
  • Diagnosis must be made by surgical biopsy or excision
  • The tumor must be supratentorial in location
  • The patient must have recovered from the effects of surgery, post-operative infection, or other complications before study entry
  • Radiotherapy must begin =\< five weeks after surgery, and Iressa (gefitinib) must begin one week prior to radiotherapy
  • Patients must have an estimated survival of at least 8 weeks
  • Zubrod performance status of 0-1
  • A diagnostic contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) scan must be performed preoperatively and postoperatively prior to the initiation of radiotherapy; preoperative and postoperative scans must be the same type
  • Patients diagnosed only by stereotactic biopsy do not require the postoperative scan
  • Patients unable to undergo magnetic resonance (MR) imaging because of non-compatible devices can be enrolled, provided pre and postoperative CT scans are obtained and are of sufficient quality
  • Hemoglobin \>= 10 grams
  • Absolute neutrophil count \>= 1500 (ANC) per mm\^3
  • Platelets \>= 100,000 per mm\^3
  • Blood urea nitrogen (BUN) =\< 25 mg
  • Creatinine =\< 1.5 mg
  • +4 more criteria

You may not qualify if:

  • Recurrent or multifocal malignant gliomas
  • Metastases detected below the tentorium or beyond the cranial vault
  • Major medical illnesses or psychiatric impairments which, in the investigator's opinion, will prevent administration or completion of protocol therapy
  • Previous radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
  • Active connective tissue disorders, such as lupus or scleroderma which, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity
  • Previous malignancies, except for non-melanomatous skin cancers and carcinoma in situ of the uterine cervix or bladder, unless disease-free for \>= 3 years
  • Prior chemotherapy or radiosensitizers for cancers of the head and neck region
  • Patients with known acquired immune deficiency (AIDS); patients with AIDS require complex therapeutic regimens; the pharmacokinetic interactions of these regimens with ZD 1839 are unknown and therefore, pose a safety risk related to excess toxicity or interference with anti-viral effectiveness
  • Patients with known multiple sclerosis, as these patients may have decreased tolerance for radiation therapy to the brain
  • Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug
  • Patients treated on any other clinical protocols within 30 days prior to study entry or during participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Therapy Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

GlioblastomaGliosarcoma

Interventions

GefitinibRadiotherapyRadiation

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeuticsPhysical Phenomena

Study Officials

  • Arnab Chakravarti

    Radiation Therapy Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

March 1, 2002

Primary Completion

June 1, 2005

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

US(1)