Trial · NCT00369590

VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide

NCT00369590, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-10-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide. Trials, record NCT00369590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00369590

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide
NCT number: NCT00369590
Status: Completed
Phases: Phase 2
Enrollment: 58 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Interventions: ziv-aflibercept, pharmacological study, laboratory biomarker analysis
First posted: 2006-08-29
Last updated: 2015-10-02
Results first posted: 2015-10-02

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS) at 6 Months	6 months	This design yields 85% power to detect a true 30% 6-month PFS rate, while maintaining .91 probability of rejecting for a true 15% 6-month PFS rate. pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression. Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no \> than maximum dose used in first 8 weeks of treatment. Stable: Does not qualify for CR, PR, or progression steroid dose no \> than maximum dose used in first 8 weeks of treatment. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening.
Primary	Safety Profile - Toxicities	Start to End of treatment 39 cycles or 1yr 7.5months (78 weeks)	number of cycles patient was able to have before developing a toxicity that required removing the patient from treatment. Treatment: Aflibercept 4mg/kg intravenously on day 1 of every 14-day cycle - 2 week cycle.
Primary	Safety Profile - Events That Discontinued Treatment	Approximately 1 year (start of treatment - end of treatment)	number of patients who experienced toxicity that led to being taken off treatment
Secondary	Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response	Up to 2 years	pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression. All responders were centrally reviewed for confirmation Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no \> than maximum dose used in first 8 weeks of treatment. Stable: Does not qualify for CR, PR, or progression steroid dose no \> than maximum dose used in first 8 weeks of treatment. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening.
Secondary	Progression Free Survival (PFS) Rate for Subjects With Radiographic Response	up to 3 years	pts with confirmed radiographic response and their rate of progression (PFS). Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no \> than maximum dose used in first 8 weeks of treatment. Stable: Does not qualify for CR, PR, or progression steroid dose no \> than maximum dose used in first 8 weeks of treatment. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening.
Secondary	Overall Survival	3 years	all patients alive as of the last contact were censored for survival on the basis of that contact date

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS) at 6 Months	6 months	pts not known to be progression free at time of the 6-month scan (24weeks) were considered to experienced treatment failure. If at least 10pts (24%) are progression-frree at 6months (GBM) the agent will be considered promising for futher study.~The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis	percentage of participants	NUMBER
SECONDARY	Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response	Up to 2 years	The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis	participants	NUMBER
PRIMARY	Safety Profile - Toxicities	Start to End of treatment 39 cycles or 1yr 7.5months (78 weeks)		cycles	MEDIAN
PRIMARY	Safety Profile - Events That Discontinued Treatment	Approximately 1 year (start of treatment - end of treatment)		participants	NUMBER
SECONDARY	Progression Free Survival (PFS) Rate for Subjects With Radiographic Response	up to 3 years	Arm1 had total of 7 pts with response however, 2 pts stopped treatment early and were censored at 6 and 10 weeks.~Arm 2 had total to 7 pts with response however 1 pt stopped treatment after 2 weeks but had a 4 week scan showing PR. - pt was censored.	weeks	MEDIAN
SECONDARY	Overall Survival	3 years	The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis	weeks	MEDIAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS) at 6 Months	Arm I - Anaplastic Glioma		25		percentage of participants
Progression-free Survival (PFS) at 6 Months	Arm 2 - Glioblastoma		7.7		percentage of participants
Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response	Arm I - Anaplastic Glioma	Complete Response	1		participants
Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response	Arm 2 - Glioblastoma	Complete Response	0		participants
Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response	Arm I - Anaplastic Glioma	Partial Response	6		participants
Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response	Arm 2 - Glioblastoma	Partial Response	7		participants
Safety Profile - Toxicities	Arm I - Anaplastic Glioma		5	Full Range 1 to 39	cycles
Safety Profile - Toxicities	Arm 2 - Glioblastoma		3.5	Full Range 0 to 8	cycles
Safety Profile - Events That Discontinued Treatment	Arm I - Anaplastic Glioma		8		participants
Safety Profile - Events That Discontinued Treatment	Arm 2 - Glioblastoma		6		participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I - Anaplastic Glioma	16
Overall Study	STARTED	Arm 2 - Glioblastoma	42
Overall Study	COMPLETED	Arm I - Anaplastic Glioma	16
Overall Study	COMPLETED	Arm 2 - Glioblastoma	42
Overall Study	NOT COMPLETED	Arm I - Anaplastic Glioma	0
Overall Study	NOT COMPLETED	Arm 2 - Glioblastoma	0

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ataxia	Nervous system disorders	All Study Patients	1	58	1
other	confusion	Psychiatric disorders	All Study Patients	1	58	1
other	dysphaia	Nervous system disorders	All Study Patients	1	58	1
other	fatigue	General disorders	All Study Patients	3	58	3
other	palmar-plantar erythrodysesthesia syndrom	Skin and subcutaneous tissue disorders	All Study Patients	1	58	1
other	headache	Nervous system disorders	All Study Patients	1	58	1
other	hypertension	Vascular disorders	All Study Patients	6	58	6
other	hyponatremia	Metabolism and nutrition disorders	All Study Patients	2	58	2
other	hypophosphatejia	Metabolism and nutrition disorders	All Study Patients	2	58	2
other	hypoxia	Respiratory, thoracic and mediastinal disorders	All Study Patients	1	58	1

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	All Study Patients
Total, other adverse events	All Study Patients	35	58
Total, serious adverse events	All Study Patients	3	58

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21606416	BACKGROUND	PubMed
21632852	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01CA062399	NABTC Central Operation Grant (UCSF Project Leader)	PRADOS, MICHAEL D	UNIVERSITY OF CALIFORNIA, SAN FRANCISCO	NATIONAL CANCER INSTITUTE	1994 to 2008

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm I - Anaplastic Glioma vs Arm 2 - Glioblastoma: Safety Profile - Events That Discontinued Treatment

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00369590

GET https://conductscience.org/api/trials/v1/NCT00369590/events?page=2

API reference For AI assistants