Malignant GliomaPhase 2ACT IIINCT00458601
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
A Phase 2 study testing CDX-110 with GM-CSF and Temozolomide in people with Malignant Glioma, run by Celldex Therapeutics at 34 sites in United States.
Trial summary
This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- CDX-110 with GM-CSF and Temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 34 sitesUnited States
- Study dates
- Aug 2007to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
- Gross total resection followed by conventional chemoradiation therapy without progression of disease.
Who cannot join
- Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
- Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
- Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
- Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Celldex Investigational Site
Amherst, New York, 14226
Celldex Investigational Site
Boston, Massachusetts, 02115
Celldex Investigational Site
Charlottesville, Virginia, 22908
Celldex Investigational Site
Chicago, Illinois, 60611
Celldex Investigational Site
Cincinnati, Ohio, 45219
Celldex Investigational Site
Cincinnati, Ohio, 45267-0502
Celldex Investigational Site
Cincinnati, Ohio, 45267-0769
Celldex Investigational Site
Cleveland, Ohio, 44106
Celldex Investigational Site
Cleveland, Ohio, 44195
Celldex Investigational Site
Durham, North Carolina, 27710
Celldex Investigational Site
Evanston, Illinois, 60201
Celldex Investigational Site
Gainesville, Florida, 32610-0277
Celldex Investigational Site
Hackensack, New Jersey, 07601
Celldex Investigational Site
Houston, Texas, 77030
Celldex Investigational Site
Lansing, Michigan, 48912
Celldex Investigational Site
New Haven, Connecticut, 06510
Celldex Investigational Site
New Haven, Connecticut, 06519
Celldex Investigational Site
New Haven, Connecticut, 06520
Celldex Investigational Site
New York, New York, 10032
Celldex Investigational Site
New York, New York, 10065
Celldex Investigational Site
Orange, California, 92868
Celldex Investigational Site
Orange, Ohio, 44122
Celldex Investigational Site
Philadelphia, Pennsylvania, 19104
Celldex Investigational Site
Saginaw, Michigan, 48601
Celldex Investigational Site
Saginaw, Michigan, 48604
Celldex Investigational Site
Salt Lake City, Utah, 84112
Celldex Investigational Site
San Antonio, Texas, 78229
Celldex Investigational Site
San Francisco, California, 94143-0622
Celldex Investigational Site
San Francisco, California, 94143
Celldex Investigational Site
Seattle, Washington, 98195
Celldex Investigational Site
Stanford, California, 94305-5826
Celldex Investigational Site
Stanford, California, 94305
Celldex Investigational Site
West Chester, Ohio, 45069-6542
Celldex Investigational Site
Westlake, Ohio, 44145
About this study
Official title: A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.
- Conditions
- Malignant Glioma
- Being tested
- CDX-110 with GM-CSF, Temozolomide
- Keywords
- EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-110 with GM-CSFDrug
Also called CDX-110 with sargramostim (GM-CSF) (Leukine®)
Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
TemozolomideDrug
Also called Temodar
Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.
| Study group | Role | What they receive |
|---|---|---|
| CDX-110 with GM-CSF | Experimental | Not described Receives: Drug: CDX-110 with GM-CSF; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival status
Measured: 5.5mo
Secondary outcomes (9)
Safety and tolerability characterized by adverse events (term, grade, frequency).
Measured: 2 years
Safety and tolerability characterized by physical examinations.
Measured: 2 years
Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).
Measured: 2 years
Safety and tolerability characterized by urinalysis.
Measured: 2 years
Safety and tolerability characterized by vital signs.
Measured: 2 years
Immune response; T-cell response to vaccine.
Measured: 2 years
Immune response; antibody response to vaccine.
Measured: 2 years
Immune response; HLA typing.
Measured: 2 years
Overall survival.
Measured: indeterminate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2010
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458601
- Sponsor's protocol ID
- CDX110-003
- Other IDs
- CDX110-003
- Acronym
- ACT III
- Status last verified
- Aug 2016
- First submitted
- 10 Apr 2007
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Schuster J, Lai RK, Recht LD, Reardon DA, Paleologos NA, Groves MD, Mrugala MM, Jensen R, Baehring JM, Sloan A, Archer GE, Bigner DD, Cruickshank S, Green JA, Keler T, Davis TA, Heimberger AB, Sampson JH. A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. Neuro Oncol. 2015 Jun;17(6):854-61. doi: 10.1093/neuonc/nou348. Epub 2015 Jan 13.
PubMed 25586468
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00458601
- Acronym / sponsor ID
- ACT III / CDX110-003
- Conditions
- Malignant Glioma
- Keywords
- EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDX-110 with GM-CSF | Experimental | Drug: CDX-110 with GM-CSF, Drug: Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
- Gross total resection followed by conventional chemoradiation therapy without progression of disease.
Key exclusion criteria (4 listed)
- Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
- Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
- Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
- Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
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 |
|---|---|---|
| CDX-110 with GM-CSFAlso: CDX-110 with sargramostim (GM-CSF) (Leukine®)Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF. | Drug | CDX-110 with GM-CSF |
| TemozolomideAlso: TemodarMaintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression. | Drug | CDX-110 with GM-CSF |
Primary outcome
Progression-free survival status
Time frame: 5.5mo
9 secondary outcomes
Safety and tolerability characterized by adverse events (term, grade, frequency).
Time frame: 2 years
Safety and tolerability characterized by physical examinations.
Time frame: 2 years
Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).
Time frame: 2 years
Safety and tolerability characterized by urinalysis.
Time frame: 2 years
Safety and tolerability characterized by vital signs.
Time frame: 2 years
Immune response; T-cell response to vaccine.
Time frame: 2 years
Immune response; antibody response to vaccine.
Time frame: 2 years
Immune response; HLA typing.
Time frame: 2 years
Overall survival.
Time frame: indeterminate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Results publication: PubMed 25586468Schuster J, Lai RK, Recht LD, Reardon DA, Paleologos NA, Groves MD, Mrugala MM, Jensen R, Baehring JM, Sloan A, Archer GE, Bigner DD, Cruickshank S, Green JA, Keler T, Davis TA, Heimberger AB, Sampson JH. A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. Neuro Oncol. 2015 Jun;17(6):854-61. doi: 10.1093/neuonc/nou348. Epub 2015 Jan 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDX-110 with GM-CSF and Temozolomide in people with Malignant Glioma, run by Celldex Therapeutics at 34 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival status (time frame: 5.5mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458601, which also lists 1 linked publication.
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 16 Jan 2018.