Exclusion Criteria: 1. Patient unable to comply with the protocol regulations. Pregnant or lactating female. Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.
The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study. Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed not mandatory in asymptomatic patients. Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment. Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
Clinically significant acute viral, bacterial, or fungal infection. Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
History of allergies to reagents used in this study. Drug abuse or extensive use of alcohol. This information was retrieved directly from the website clinicaltrials. If you have any requests to change, remove or update your study details, please contact [email protected]. Study was discontinued early due to the inability to recruit a sufficient number of participants. Baseline Analysis Population Description The Intent-to-treat population includes all participants randomized.
Measure Description: Study was discontinued early because of the inability to recruit a sufficient number of suitable participants within the planned recruitment period, therefore not all planned sites recruited participants.
Only those regions that recruited at least one participant are listed. Measure Description: Height is missing for one participant in the Chemotherapy group. Measure Description: Weight is missing for one participant in the Chemotherapy group.
Measure Description: Twenty-six participants were diagnosed with Anaplastic Astrocytoma, and one participant was diagnosed with Secondary Glioblastoma Multiforme.
Measure Description: Time of first diagnosis in years before study entry is available for all 14 participants in the Trabedersen group and 11 participants in the chemotherapy group. Measure Description: Time of first diagnosis in years before study entry of Secondary Glioblastoma Multiforme. No participants in this group were diagnosed with Secondary Glioblastoma Multiforme. One participant in this group was diagnosed with Secondary Glioblastoma Multiforme. Description Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization.
If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis Population Description. The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis.
Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented. Title Survival at 24 Months in the Intent-to-treat Population - Number of Participants Description Survival status was assessed at 24 months from randomization. Description Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.
Title Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants Descriptive Analysis, Only Description Survival rate was defined as the proportion of participants known to b Description Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization.
Title Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants Description Survival status was assessed at each time-point from randomization. Description Survival status was assessed at each time-point from randomization. The category "Lost to follow-up" for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point. Description Median overall survival was defined as the date of randomization to the date of death.
Analysis was by Kaplan-Meier estimation. Title Response Category by Independent Review in the Intent-to-treat Population - Number of Participants Description Tumor response was classified based on the neuro- radiologist's evalu Description Tumor response was classified based on the neuro- radiologist's evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below: Complete Response CR : Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.
Stable Disease SD : all other situations. Description Overall response rate was the proportion of participants with a best response of Complete Response CR or Partial Response PR observed from the start of treatment until disease progression.
Participants with unknown or missing response were treated as non-responders. Description Duration of response was defined as the time from the first documentation of confirmed response Complete Response, CR, or Partial Response, PR to the first signs of Progressive Disease PD , as assessed by the study neuro-oncologist.
Censoring rules were: at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death.
Due to early discontinuation of study, an insufficient number of patients reached this endpoint for estimation. Title Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants Description Tumor response was classified based on the neuro- radiologist's evalu Description Tumor response was classified based on the neuro- radiologist's evaluation: Complete Response CR : Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.
Description Time to progression was calculated from the date of randomization to the date of the first documented tumor progression. Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death. Time Frame Safety monitoring including adverse events started from the signature of the informed consent and continued until 28 days after the last administration of study drug, up to 24 months.
Adverse events including lab tests were assessed at study visits. Indicates events were collected by systematic assessment. Term from vocabulary, MedDRA Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Outcome Measures. Primary Outcome Measures : Overall response rate of two AP dose groups and control group assessed by the evaluation of tumor size on brain MRI scans.
Secondary Outcome Measures : Overall survival [ Time Frame: overall ] Overall survival [ Time Frame: six- and twelve-month ] Response rates [ Time Frame: at 3, 8, 10, and 12 months and during the prolonged follow-up period in six-monthly intervals, if applicable ] Progression-free survival [ Time Frame: six-month ] Time to progression Time to response Best of all response rates assessed by survival status and variation of tumor size on brain MRI Change of quality of life and Karnofsky Performance Status KPS [ Time Frame: at 3, 8, 10, and 12 months and during the prolonged follow-up period in six-monthly intervals, if applicable ] Best of all response rates Safety and tolerability.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Kirov, Neurosurgery Department St.
More Information. Publications automatically indexed to this study by ClinicalTrials. Cancers Basel. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Glioblastoma Anaplastic Astrocytoma.
Phase 2.
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