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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

Phase 0
18 Years
Open (Enrolling)
Astrocytoma, Oligo-Astrocytoma, Glioma

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Trial Information

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

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.

Inclusion Criteria:

- Participants must have documented pathological diagnosis of a WHO grade II
astrocytoma or oligoastrocytoma or oligodendroglioma (see also the 4th bullet for

- 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).

- 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.

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Induction of GAA-specific T-cell response

Outcome Time Frame:

2 year

Safety Issue:


Principal Investigator

Frank Lieberman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

November 2014

Related Keywords:

  • Astrocytoma
  • Oligo-Astrocytoma
  • Glioma
  • vaccine
  • WHO Grade II Astrocytoma
  • WHO Grade II Oligo-Astrocytoma
  • Astrocytoma
  • Glioma
  • Oligodendroglioma



University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina  27157-1082