Adult Giant Cell GlioblastomaPhase 2NCT00112866
Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme
A Phase 2 study testing cilengitide, therapeutic conventional surgery and pharmacological study in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
- What is being tested?
- cilengitide, therapeutic conventional surgery and pharmacological study
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed intracranial glioblastoma multiforme (GBM)
- Original diagnosis of low-grade glioma with subsequent histological confirmation of GBM allowed
- Recurrent disease
- Failed prior radiotherapy
- Must require a surgical procedure (gross total or near gross total resection) for tumor removal
- Performance status - Karnofsky 60-100%
Show all 41Show fewer
- White Blood Count (WBC) ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- Serum glutamic oxaloacetic transaminase (SGOT) < 2 times upper limit of normal (ULN)
- Bilirubin < 2 times ULN
- Creatinine < 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for ≥ 2 weeks after study participation (for female patients) or for 3 months after study participation (for male patients)
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No active infection
- No other significant uncontrolled medical illness that would preclude study participation
- At least 3 weeks since prior interferon
- No prior cilengitide
- No other prior targeted antiangiogenic treatment (e.g., vatalanib, SU5416, or thalidomide)
- No concurrent anticancer immunotherapy
- No concurrent routine prophylactic filgrastim (G-CSF)
- At least 2 weeks since prior vincristine
- At least 3 weeks since prior procarbazine
- At least 6 weeks since prior nitrosoureas
- No concurrent anticancer chemotherapy
- At least 3 weeks since prior tamoxifen
- No concurrent anticancer hormonal therapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent anticancer radiotherapy
- Recovered from all prior therapies
- No more than 3 prior treatments for GBM (1 initial treatment; and treatment for 2 relapses)
- For patients who received prior therapy for low-grade glioma, a subsequent surgical diagnosis of high-grade glioma is considered the first relapse
- At least 4 weeks since prior investigational agents
- At least 4 weeks since prior cytotoxic therapy
- At least 3 weeks since other prior non-cytotoxic therapy (e.g., isotretinoin), except radiosensitizers
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
North American Brain Tumor Consortium
Watertown, Massachusetts, 02472
About this study
Official title: Phase II Trial of EMD 121974 for Recurrent Glioblastoma: A Clinical Trial With Tissue Correlates of Response
Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme. This phase II trial is studying how well cilengitide works in treating patients who are undergoing surgery for recurrent or progressive glioblastoma multiforme.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the 6-month progression-free survival rate in operative patients with recurrent or progressive glioblastoma multiforme treated with cilengitide.
SECONDARY OBJECTIVES:
- Determine the safety and toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment groups for the preoperative treatment component.
Preoperative Treatment Group I: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1.
Preoperative Treatment Group II: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1.
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per preoperative treatment group) will be accrued for this study.
- Conditions
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Being tested
- cilengitide, therapeutic conventional surgery, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilengitideDrug
Also called EMD 121974
Given IV
therapeutic conventional surgeryProcedure or surgery
Undergo tumor resection
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (high-dose cilengitide) 2000mg | Experimental | Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: cilengitide; Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
| Group II (low-dose cilengitide) 500mg | Experimental | Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (500mg)
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity Receives: Drug: cilengitide; Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
6m-Progression-free Survival
progression within 6 months (26 weeks) of treatment
Measured: 6 months
Secondary outcomes (7)
Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells
Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Measured: Baseline and time of surgery
Changes in Vitronectin Expression
Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Measured: Baseline and time of surgery
Changes in Tumor Cell Apoptosis
Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Measured: Baseline and time of surgery
Changes in Tumor Cell Proliferation
Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Measured: Baseline and time of surgery
Changes in Endothelial Cell Apoptosis
Will be performed between the untreated matched control tumor tissue and the tissue obtained from the post-treatment tumors using either a Fisher's Exact test or the Wilcoxon rank sum test depending on whether the assay provides a measurement or is yes/no.
Measured: Baseline and up to 4 years
Plasma Concentration of EMD 121974
24 hour post dose concentration plasma, at time of resection
Measured: 24 hour post concentration
Tumor Tissue Concentrations
a section of tumor of approximately 500mg will be snap frozen (immediately prepared and frozen) once removed from brain for analysis of the drug concentration in contrast -enhancing tumor.
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2008
- Study completionMar 2009
Why it stopped: due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Gilbert, Principal investigator, North American Brain Tumor Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112866
- Sponsor's protocol ID
- NCI-2012-02653
- Other IDs
- NCI-2012-02653, CDR0000428409, NABTC-03-02, NABTC-03-02, U01CA062399
- Status last verified
- May 2017
- First submitted
- 2 Jun 2005
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of EMD 121974 for Recurrent Glioblastoma: A Clinical Trial With Tissue Correlates of Response
- ClinicalTrials.gov ID
- NCT00112866
- Acronym / sponsor ID
- NCI-2012-02653
- Conditions
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to poor accrual
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Jun 2005 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme. This phase II trial is studying how well cilengitide works in treating patients who are undergoing surgery for recurrent or progressive glioblastoma multiforme.
Detailed description
PRIMARY OBJECTIVES:
- Determine the 6-month progression-free survival rate in operative patients with recurrent or progressive glioblastoma multiforme treated with cilengitide.
SECONDARY OBJECTIVES:
- Determine the safety and toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment groups for the preoperative treatment component.
Preoperative Treatment Group I: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1.
Preoperative Treatment Group II: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1.
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per preoperative treatment group) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (high-dose cilengitide) 2000mg | Experimental | Drug: cilengitide, Procedure: therapeutic conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPreoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg) Resection: All patients undergo tumor resection on day 0. Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. |
| Group II (low-dose cilengitide) 500mg | Experimental | Drug: cilengitide, Procedure: therapeutic conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPreoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (500mg) Resection: All patients undergo tumor resection on day 0. Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Histologically confirmed intracranial glioblastoma multiforme (GBM)
- Must require a surgical procedure (gross total or near gross total resection) for tumor removal
- Performance status - Karnofsky 60-100%
- White Blood Count (WBC) ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| cilengitideAlso: EMD 121974Given IV | Drug | Group I (high-dose cilengitide) 2000mg, Group II (low-dose cilengitide) 500mg |
| therapeutic conventional surgeryUndergo tumor resection | Procedure or surgery | Group I (high-dose cilengitide) 2000mg, Group II (low-dose cilengitide) 500mg |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Group I (high-dose cilengitide) 2000mg, Group II (low-dose cilengitide) 500mg |
| laboratory biomarker analysisCorrelative studies | Other | Group I (high-dose cilengitide) 2000mg, Group II (low-dose cilengitide) 500mg |
Primary outcome
6m-Progression-free Survival
Time frame: 6 months
progression within 6 months (26 weeks) of treatment
7 secondary outcomes
Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells
Time frame: Baseline and time of surgery
Changes in Vitronectin Expression
Time frame: Baseline and time of surgery
Changes in Tumor Cell Apoptosis
Time frame: Baseline and time of surgery
Changes in Tumor Cell Proliferation
Time frame: Baseline and time of surgery
Changes in Endothelial Cell Apoptosis
Time frame: Baseline and up to 4 years
Plasma Concentration of EMD 121974
Time frame: 24 hour post concentration
Tumor Tissue Concentrations
Time frame: at time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 1
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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.
Mark Gilbert principal investigator
North American Brain Tumor Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cilengitide, therapeutic conventional surgery and pharmacological study 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 41 inclusion and 0 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: stopped early, as of the sponsor's last update on 14 Jun 2017. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6m-Progression-free Survival (time frame: 6 months). 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 14 Jun 2017.