AstrocytomaEarly Phase 1NCT00795457
Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With High-Risk WHO Grade II Astrocytomas and Oligo-Astrocytomas
A Early Phase 1 study testing GAA/TT-peptide vaccine and poly-ICLC in people with Astrocytoma and Oligo-Astrocytoma, run by Ian F. Pollack, M.D. at 2 sites in United States.
Trial summary
This is a pilot vaccine study in adults with either WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in combination with the study drug Poly-ICLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Oligo-Astrocytoma, Glioma
- What is being tested?
- GAA/TT-peptide vaccine and poly-ICLC
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Jul 2015
- Phase
- Early Phase 1
- 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
- Participants must have documented pathological diagnosis of a WHO grade II astrocytoma or oligoastrocytoma or oligodendroglioma (see also the 4th bullet for oligodendroglioma).
- HLA-A2 positive based on flow cytometry.
- There will be 2 cohorts of patients based on whether patients have received prior RT. Cohort 1: patients must have undergone surgery or biopsy alone ≤16 weeks prior to study entry (no postoperative radiation or chemotherapy). Cohort 2: Patients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery), which was completed ≥6 months prior to enrollment, and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression.
- For oligodendroglioma, at least one of the following three conditions has to be met: 1) age ≥ 40 with any extent resection; 2) age 18-39 with incomplete resection (post-op MRI showing > 1cm residual disease, based on the maximum dimension of residual T2 or FLAIR abnormality from the edge of the surgical cavity either laterally, antero-posteriorly, or supero-inferiorly) or 3) age 18-39 with neurosurgeon-defined GTR but the tumor size is ≥ 4 cm (the maximum preoperative tumor diameter, based on the axial and/or coronal T2 or FLAIR MR images). Participants must be ≥ 18 years old because the safety of each therapeutic component has not been established in children.
- All participants must sign an informed consent document indicating that they are aware of the investigational nature of this study.
- Participants must have a Karnofsky performance status of > 60 (Appendix I).
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- Documented negative serum beta HCG for female participants of child-bearing age. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the peptide based vaccine and poly-ICLC, breastfeeding should be discontinued if the mother is treated in this study.
- Participants must be free of systemic infection
- Participants with adequate organ function as measured by white blood count ≥ 2500/mm3; lymphocytes ≥ 800/mm3; platelets ≥ 100,000/mm3, hemoglobin ≥ 10.0 g/dL, AST, ALT, GGT, LDH, alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin greater than or equal to 2.0 mg/dL, and serum creatinine within 1.5 X upper limit of normal limit. Coagulation tests PT and PTT have to be within normal limits.
Who cannot join
- Presence of cranial or spinal leptomeningeal metastatic disease.
- Prior chemotherapy or anti-glioma therapy of any type other than radiation therapy (see 3.1.3)
- Concurrent treatment or medications including:
- Radiation therapy
- Chemotherapy
- Interferon
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- Allergy desensitization injections
- Growth factors
- Interleukins
- Any investigational therapeutic medication
- Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. Mild arthritis requiring NSAID medications will not be exclusionary.
- Use of immunosuppressives within 4 weeks prior to study entry or anticipated use of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used perioperative period and/or during radiotherapy, must be tapered and discontinued at least 4 weeks before administration of the first vaccine. Topical corticosteroids and Inhaled steroids are acceptable.
- Participants who have another cancer diagnosis, except that the following diagnoses will be allowed:
- squamous cell cancer of the skin without known metastasis
- basal cell cancer of the skin without known metastasis
- carcinoma in situ of the breast (DCIS or LCIS)
- carcinoma in situ of the cervix
- any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years
- Participants with known addiction to alcohol or any drugs.
- Because patients with immune deficiency are not expected to respond to this therapy, HIV positive patients are excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157-1030
About this study
Official title: A Bi-Institutional Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With WHO Grade II Low-Grade Gliomas
This is a pilot vaccine study in adults with either WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in combination with the study drug Poly-ICLC.
Poly-ICLC, manufactured by Oncovir, Inc., has already been received and generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases.
The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted in each of two patient cohorts.
Read the detailed description
All patients on the study will be followed for a minimum of 2 years, so that the actual 2-year overall survival (OS) and progression-free survival (PFS) rates can be determined in an exploratory manner.
- Conditions
- Astrocytoma, Oligo-Astrocytoma, Glioma
- Being tested
- GAA/TT-peptide vaccine and poly-ICLC
- Keywords
- vaccine, WHO Grade II Astrocytoma, WHO Grade II Oligo-Astrocytoma
- Medical subject headings
- Astrocytoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAA/TT-peptide vaccine and poly-ICLCBiological
Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
GAA/TT-peptide vaccine and poly-ICLCBiological
Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients must have undergone surgery or biopsy alone ≤16 weeks prior to study entry (no postoperative radiation or chemotherapy). Receives: Biological: GAA/TT-peptide vaccine and poly-ICLC |
| 2 | Experimental | Patients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery), which was completed ≥6 months prior to enrollment, and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression. Receives: Biological: GAA/TT-peptide vaccine and poly-ICLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of GAA-specific T-cell response
Measured: 2 year
The incidence and severity of adverse events associated with the vaccine regime will be assessed, with an early stopping rule based on the frequency of Regimen Limiting Toxicity (RLT).
Measured: 1 year
Secondary outcomes (3)
Clinical Response: Radiological response will be determined using the standard WHO response criteria. Based on serial magnetic resonance imaging (MRI) scans 2-year progression-free survival (PFS) will be evaluated in an exploratory manner.
Measured: 3 years
Biopsy/resection will be encouraged for patients who develop progression. Whenever post-vaccine tumor tissues are available, they will be analyzed for GAA expression status and infiltration of GAA-specific T-cells.
Measured: 3 years
Influence of RT on induction of GAA-specific immune response: we will compare the rate and magnitude of GAA-specific immune responses in Cohorts 1 and Cohort 2 using IFN-gamma-enzyme-linked immuno-spot (ELISPOT), and tetramer assays.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ian F. Pollack, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Oncovir, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Ian F. Pollack, M.D., University of Pittsburgh
- Investigators
- Frank Lieberman, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795457
- Sponsor's protocol ID
- 07-057
- Other IDs
- R21CA133859-01A1
- Status last verified
- Aug 2019
- First submitted
- 19 Nov 2008
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bi-Institutional Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With WHO Grade II Low-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00795457
- Acronym / sponsor ID
- 07-057
- Conditions
- Astrocytoma, Oligo-Astrocytoma, Glioma
- Keywords
- vaccine, WHO Grade II Astrocytoma, WHO Grade II Oligo-Astrocytoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ian F. Pollack, M.D.University, hospital or other
- Collaborators
- Oncovir, Inc., National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Nov 2008 (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 is a pilot vaccine study in adults with either WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in combination with the study drug Poly-ICLC.
Poly-ICLC, manufactured by Oncovir, Inc., has already been received and generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases.
The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted in each of two patient cohorts.
Detailed description
All patients on the study will be followed for a minimum of 2 years, so that the actual 2-year overall survival (OS) and progression-free survival (PFS) rates can be determined in an exploratory manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: GAA/TT-peptide vaccine and poly-ICLCPatients must have undergone surgery or biopsy alone ≤16 weeks prior to study entry (no postoperative radiation or chemotherapy). |
| 2 | Experimental | Biological: GAA/TT-peptide vaccine and poly-ICLCPatients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery), which was completed ≥6 months prior to enrollment, and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must have documented pathological diagnosis of a WHO grade II astrocytoma or oligoastrocytoma or oligodendroglioma (see also the 4th bullet for oligodendroglioma).
- HLA-A2 positive based on flow cytometry.
- There will be 2 cohorts of patients based on whether patients have received prior RT. Cohort 1: patients must have undergone surgery or biopsy alone ≤16 weeks prior to study entry (no postoperative radiation or chemotherapy). Cohort 2: Patients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery), which was completed ≥6 months prior to enrollment, and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression.
- For oligodendroglioma, at least one of the following three conditions has to be met: 1) age ≥ 40 with any extent resection; 2) age 18-39 with incomplete resection (post-op MRI showing > 1cm residual disease, based on the maximum dimension of residual T2 or FLAIR abnormality from the edge of the surgical cavity either laterally, antero-posteriorly, or supero-inferiorly) or 3) age 18-39 with neurosurgeon-defined GTR but the tumor size is ≥ 4 cm (the maximum preoperative tumor diameter, based on the axial and/or coronal T2 or FLAIR MR images). Participants must be ≥ 18 years old because the safety of each therapeutic component has not been established in children.
- All participants must sign an informed consent document indicating that they are aware of the investigational nature of this study.
Key exclusion criteria (20 listed)
- Presence of cranial or spinal leptomeningeal metastatic disease.
- Prior chemotherapy or anti-glioma therapy of any type other than radiation therapy (see 3.1.3)
- Concurrent treatment or medications including:
- Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. Mild arthritis requiring NSAID medications will not be exclusionary.
- Use of immunosuppressives within 4 weeks prior to study entry or anticipated use of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used perioperative period and/or during radiotherapy, must be tapered and discontinued at least 4 weeks before administration of the first vaccine. Topical corticosteroids and Inhaled steroids are acceptable.
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 |
|---|---|---|
| GAA/TT-peptide vaccine and poly-ICLCParticipants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration. | Biological | 1 |
| GAA/TT-peptide vaccine and poly-ICLCParticipants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration. | Biological | 2 |
Primary outcome
Induction of GAA-specific T-cell response
Time frame: 2 year
The incidence and severity of adverse events associated with the vaccine regime will be assessed, with an early stopping rule based on the frequency of Regimen Limiting Toxicity (RLT).
Time frame: 1 year
3 secondary outcomes
Clinical Response: Radiological response will be determined using the standard WHO response criteria. Based on serial magnetic resonance imaging (MRI) scans 2-year progression-free survival (PFS) will be evaluated in an exploratory manner.
Time frame: 3 years
Biopsy/resection will be encouraged for patients who develop progression. Whenever post-vaccine tumor tissues are available, they will be analyzed for GAA expression status and infiltration of GAA-specific T-cells.
Time frame: 3 years
Influence of RT on induction of GAA-specific immune response: we will compare the rate and magnitude of GAA-specific immune responses in Cohorts 1 and Cohort 2 using IFN-gamma-enzyme-linked immuno-spot (ELISPOT), and tetramer assays.
Time frame: 3 years
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 30 Aug 2019.
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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.
Frank Lieberman, MD principal investigator
University of Pittsburgh Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GAA/TT-peptide vaccine and poly-ICLC in people with Astrocytoma and Oligo-Astrocytoma, run by Ian F. Pollack, M.D. at 2 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 9 inclusion and 20 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Induction of GAA-specific T-cell response (time frame: 2 year). The study lists 2 primary outcomes in all. 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 30 Aug 2019.