Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365222
Status:
TERMINATED
Last Update Posted:
2009-01-22
First Post:
2006-08-15
Brief Title:
Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB Study Closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single arm Phase 2 trial with the study drug temozolomide temodar for newly diagnosed glioblastoma in elderly patients defined as greater than or equal to 70 years old Following surgical resection and confirmation of glioblastoma patients will proceed to primary chemotherapy with temozolomide temodar Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days
Procedures prior to initial study treatment 14 Days are NeurologicalOncological History Neurological Examination Height Weight and Body Surface Area Performance Status Quality Of Life FACT-BR Labs MGMT tissue analysis and Cranial CTMRI with and without contrast
The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment And the off study procedures for patients are performance status Quality Of Life FACT-BR MGMT tissue analysis and cranial CTMRI with and without contrast
Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving
Procedures prior to initial study treatment 14 Days are NeurologicalOncological History Neurological Examination Height Weight and Body Surface Area Performance Status Quality Of Life FACT-BR Labs MGMT tissue analysis and Cranial CTMRI with and without contrast
The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment And the off study procedures for patients are performance status Quality Of Life FACT-BR MGMT tissue analysis and cranial CTMRI with and without contrast
Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving
Detailed Description:
A single arm Phase 2 trial with the study drug temozolomide temodar for newly diagnosed glioblastoma in elderly patients defined as greater than or equal to 70 years old Temozolomide will be administered orally a capsule at approximately the same time daily bedtime for 42 days on and then 14 days off cycles may be repeated every 56 days Complete blood counts will be obtained bi-weekly evaluations monthly and MRIs every 2 months after a cycle of therapy
Procedures prior to initial study treatment 14 Days are NeurologicalOncological History Neurological Examination Height Weight and Body Surface Area Performance Status Quality Of Life FACT-BR Labs MGMT tissue analysis and Cranial CTMRI with and without contrast all disease found at staging must be followed using the same modality used at Pre-treatment Tumor assessments are to be repeated every 56 days thereafter until progression The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment
Patients may continue on therapy unless one of the following occurs
Documented or clinical progressive disease at any time
Unacceptable toxicity
Treatment delay of 2 weeks for any reason
Study data or other data indicate that the study treatment is not beneficial for the patients defined as at least one response in the first 12 patients within each tumor histology strata
Non-compliance by the patient with protocol requirements follow-up treatment administration of disallowed therapy
Changes in medical status of the patient such that the patient no longer meets eligibility requirements leptomeningeal spread change in mental competency or the investigator believes that patient safety will be compromised
Patient withdrawal of consent for treatment
Occurrence of one toxic death
Patients with CR PR or stable disease SD will be treated for a minimum of 3 cycles 6 months or until disease progression For patients responding to treatment continuation of therapy beyond 3 cycles is at the discretion of the investigator Response parameters will include the MacDonald criteria for evaluating brain tumors Response is measured by a reduction in tumor size
After cessation of protocol therapy patients will continue to be followed for survival at 2-month intervals for up to three years from start of treatment And the off study procedures for patients are performance status Quality Of Life FACT-BR MGMT tissue analysis and cranial CTMRI with and without contrast
Procedures prior to initial study treatment 14 Days are NeurologicalOncological History Neurological Examination Height Weight and Body Surface Area Performance Status Quality Of Life FACT-BR Labs MGMT tissue analysis and Cranial CTMRI with and without contrast all disease found at staging must be followed using the same modality used at Pre-treatment Tumor assessments are to be repeated every 56 days thereafter until progression The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment
Patients may continue on therapy unless one of the following occurs
Documented or clinical progressive disease at any time
Unacceptable toxicity
Treatment delay of 2 weeks for any reason
Study data or other data indicate that the study treatment is not beneficial for the patients defined as at least one response in the first 12 patients within each tumor histology strata
Non-compliance by the patient with protocol requirements follow-up treatment administration of disallowed therapy
Changes in medical status of the patient such that the patient no longer meets eligibility requirements leptomeningeal spread change in mental competency or the investigator believes that patient safety will be compromised
Patient withdrawal of consent for treatment
Occurrence of one toxic death
Patients with CR PR or stable disease SD will be treated for a minimum of 3 cycles 6 months or until disease progression For patients responding to treatment continuation of therapy beyond 3 cycles is at the discretion of the investigator Response parameters will include the MacDonald criteria for evaluating brain tumors Response is measured by a reduction in tumor size
After cessation of protocol therapy patients will continue to be followed for survival at 2-month intervals for up to three years from start of treatment And the off study procedures for patients are performance status Quality Of Life FACT-BR MGMT tissue analysis and cranial CTMRI with and without contrast
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None