Adult Giant Cell GlioblastomaPhase 1/2NCT00052208
Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
A Phase 1/2 study testing gefitinib, radiation therapy and laboratory biomarker analysis in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
- What is being tested?
- gefitinib, radiation therapy and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jun 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
- Bilirubin =< 2.0 mg
- Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =< 2 x normal range
- Patients must consent to submission of their tissue/serum
- The patient must sign a study-specific informed consent prior to study entry; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (Iressa), [NSC #715055] With Radiation Therapy in Glioblastoma Multiforme
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify the maximum tolerated dose of ZD 1839 (gefitinib) when given concurrently with cranial radiotherapy.
II. To determine if ZD 1839, given orally on a daily basis starting at the time of conventional radiation therapy (RT), may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme, compared with historical controls, stratifying by epidermal growth factor receptor (EGFR) status.
III. To determine, in a multi-institutional setting, the feasibility and toxicity of prescribing ZD 1839.
SECONDARY OBJECTIVES:
- Whether ZD 1839 also improves progression-free survival in these patients.
OUTLINE: This is a phase I, dose-escalation study of gefitinib followed by a phase II study.
Patients receive gefitinib orally (PO) once daily (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.
After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and annually thereafter.
- Being tested
- gefitinib, radiation therapy, laboratory biomarker analysis
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
Also called Iressa, ZD 1839
Given PO
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: gefitinib; Radiation: radiation therapy; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 10 years
Overall survival, by EGFR status
Measured: Up to 10 years
Secondary outcomes (1)
Progression-free survival
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Giant Cell GlioblastomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Arnab Chakravarti, Principal investigator, Radiation Therapy Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052208
- Sponsor's protocol ID
- NCI-2013-00849
- Other IDs
- RTOG-0211, CDR0000069330, RTOG-BR-0211, U10CA021661
- Status last verified
- Oct 2020
- First submitted
- 24 Jan 2003
- Last updated
- 30 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (Iressa), [NSC #715055] With Radiation Therapy in Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00052208
- Acronym / sponsor ID
- NCI-2013-00849
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- NRG Oncology
- Study start
- Mar 2002
- Primary completion
- Jun 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To identify the maximum tolerated dose of ZD 1839 (gefitinib) when given concurrently with cranial radiotherapy.
II. To determine if ZD 1839, given orally on a daily basis starting at the time of conventional radiation therapy (RT), may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme, compared with historical controls, stratifying by epidermal growth factor receptor (EGFR) status.
III. To determine, in a multi-institutional setting, the feasibility and toxicity of prescribing ZD 1839.
SECONDARY OBJECTIVES:
- Whether ZD 1839 also improves progression-free survival in these patients.
OUTLINE: This is a phase I, dose-escalation study of gefitinib followed by a phase II study.
Patients receive gefitinib orally (PO) once daily (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.
After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (gefitinib, radiation therapy) | Experimental | Drug: gefitinib, Radiation: radiation therapy, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gefitinibAlso: Iressa, ZD 1839Given PO | Drug | Treatment (gefitinib, radiation therapy) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Treatment (gefitinib, radiation therapy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (gefitinib, radiation therapy) |
Primary outcome
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
Time frame: 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
Time frame: Up to 10 years
Overall survival, by EGFR status
Time frame: Up to 10 years
1 secondary outcome
Progression-free survival
Time frame: Up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
Related trials for Adult Giant Cell Glioblastoma
Active, not recruitingPhase 1
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnab Chakravarti principal investigator
Radiation Therapy Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing gefitinib, radiation therapy and laboratory biomarker analysis in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Within 90 days from the start of radiotherapy treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.