Gefitinib (Iressa) and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Pediatric Brain Tumor Consortium

ClinicalTrials.gov Identifier:

NCT00042991

First received: August 5, 2002

Last updated: June 13, 2011

Last verified: June 2011

History of Changes

Results First Received: February 9, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Brain and Central Nervous System Tumors
Interventions:	Drug: Gefitinib Radiation: Local Irradiation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Accrual to this study started with the first patient who enrolled on 07/01/2002 and ended with the last patient who enrolled on 05/31/2006. Nine institutions enrolled patients on the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no randomization to the three strata, which were distinct based on diagnosis and the use of enzyme inducing anti-convulsants (EIACD).

Reporting Groups

	Description
Stratum 1A-100 mg/m^2 of Gefitinib + Radiation	These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
Stratum 1A-250 mg/m^2 of Gefitinib + Radiation	These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
Stratum 1A-375 mg/m^2 of Gefitinib + Radiation	These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation	These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation	These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation	These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD	These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.

Participant Flow: Overall Study

	Stratum 1A-100 mg/m^2 of Gefitinib + Radiation	Stratum 1A-250 mg/m^2 of Gefitinib + Radiation	Stratum 1A-375 mg/m^2 of Gefitinib + Radiation	Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation	Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation	Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation	Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD
STARTED	6	43 ^[1]	7	2	3	5	3
Phase-I Trial	6	7 ^[2]	7	2	3	5	3
Phase-II Trial	0	36	0	0	0	0	0
COMPLETED	0	3	1	0	0	0	1
NOT COMPLETED	6	40	6	2	3	5	2
Adverse Event	1	4	2	0	0	1	0
Withdrawal by Subject	0	7	2	0	1	0	0
Disease Progression	5	29	2	2	1	4	2
Alternative Therapy	0	0	0	0	1	0	0

[1]	These 43 patients form the Phase-II cohort, seven contributing from the Phase-I trial.
[2]	These seven patients contributed to both Phase-I and Phase-II objectives.

Baseline Characteristics

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Outcome Measures

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1. Primary:

Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy [ Time Frame: Day 1 of gefitinib therapy to end of week 8 ]

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2. Primary:

Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas [ Time Frame: Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks ]

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3. Primary:

Median Survival in Newly Diagnosed Brain Stem Gliomas [ Time Frame: Assessed from the start of therapy until three years after initiation of gefitinib therapy ]

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4. Secondary:

Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation [ Time Frame: Baseline and two weeks post completion of radiation ]

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5. Secondary:

Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation [ Time Frame: Baseline and two weeks post completion of radiation ]

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6. Secondary:

Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation [ Time Frame: Baseline and two weeks post completion of radiation ]

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7. Secondary:

Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation [ Time Frame: Baseline and two weeks post completion of radiation ]

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8. Secondary:

Mean Tumor to Gray Matter Ratio Measured at Baseline [ Time Frame: Baseline ]

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9. Secondary:

Mean Tumor to White Matter Ratio Measured at Baseline [ Time Frame: Baseline ]

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10. Secondary:

Peak Serum Concentration of Gefitinib (Cmax) [ Time Frame: Week 2 of course 1 ]

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11. Secondary:

Elimination Half Life of Gefitinib (t1/2) [ Time Frame: Week 2 of course 1 ]

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12. Secondary:

Clearance of Gefitinib (Cl) [ Time Frame: Week 2 of course 1 ]

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13. Secondary:

Time of Maximum Clearance of Gefitinib (Tmax) [ Time Frame: Week 2 of course 1 ]

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14. Secondary:

Gefitinib Area Under the Concentration Curve From 0-24 Hours (AUC) [ Time Frame: Week 2 of course 1 ]

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15. Secondary:

Number of Patients With Epidermal Growth Factor Receptor (EGFR) Amplification [ Time Frame: Pre-treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Mehmet Kocak
Organization: Operations and Biostatistics Center for Pediatric Brain Tumor Consortium (PBTC)
phone: 9015952947
e-mail: mehmet.kocak@stjude.org

No publications provided

Responsible Party:	James M. Boyett, Executive Director Operations and Biostatistics Center for the PBTC, Pediatric Brain Tumor Consortium (PBTC)
ClinicalTrials.gov Identifier:	NCT00042991 History of Changes
Other Study ID Numbers:	CDR0000069490, PBTC-007, 715055
Study First Received:	August 5, 2002
Results First Received:	February 9, 2011
Last Updated:	June 13, 2011
Health Authority:	United States: Food and Drug Administration

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