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A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With Recurrent WHO Grade II Gliomas

Phase 0
18 Years
Open (Enrolling)
Astrocytoma, Oligoastrocytoma, Oligodendroglioma

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Trial Information

A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With Recurrent WHO Grade II Gliomas

This is a pilot study of a vaccination regime that is designed to efficiently induce
anti-tumor T-cell responses in patients with recurrent WHO grade II glioma. The proposed
regime combines subcutaneous injections of glioma-associated antigen (GAA)-derived cytotoxic
T-lymphocyte (CTL) epitope-peptides with simultaneous intramuscular (i.m.) administration of

The overall objective of this pilot study is to collect immunological and safety data that
will be used to decide whether a larger study of clinical efficacy is warranted in these
patients. All patients on the study will be followed for a minimum of 2 years, so that the
actual 2-year overall survival (OS), 6-month and 2-year progression-free survival (PFS)
rates can be determined in an exploratory manner.

Inclusion Criteria:

1. Participants must have recurrent supratentorial WHO grade II astrocytoma,
oligoastrocytoma or oligodendroglioma that is histologically confirmed either by the
previous biopsy or resection, or at the time of re-operation (re-operation before
entry to the current study is allowed; however post-surgery Decadron must be off for
at least 4 weeks before administration of the first vaccine). Patients may have
received prior external beam radiotherapy and/or chemotherapy. With regard to the
prior therapy, patients may have had treatment for no more than 2 prior relapses.
Relapse is defined as progression following initial therapy (i.e. radiation +/- chemo
if that was used as initial therapy). The intent therefore is that patients may have
had 3 prior therapies (initial therapy and treatment for 2 relapses). If the patient
had a surgical resection for relapsed disease, and no anti-cancer therapy was
instituted for up to 12 weeks, and the patient undergoes another surgical resection,
this is considered as 1 relapse.

2. HLA-A2 positive based on flow cytometry.

3. Tumor recurrence is defined by the increase of maximum tumor diameter, based on the
axial and/or coronal T2 or FLAIR MR images. Increase of tumor size can be based on
comparison with previous scans performed up to prior 3 years to allow assessment of
slow-growth of the tumor.

4. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from
any investigational agent, 4 weeks from prior cytotoxic therapy and/or at least two
weeks from vincristine, 4 weeks from nitrosoureas, 3 weeks from procarbazine
administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen,
thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions
related to the definition of non-cytotoxic agents should be directed to the Principal
Investigator. With regard to previous RT, there must be at least 6 months from the
completion of RT (or radiosurgery).

5. Participants must be at least 18 years old. For patients under 18 years old, we have
a separate, but similar vaccine study through the Children's Hospital in Pittsburgh.

6. All participants must sign an informed consent document.

7. Participants must have a Karnofsky performance status of > 60 (Appendix I).

8. Documented negative serum 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. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately. 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

9. Participants must be free of systemic infection.

10. 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 ≤ 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:

1. Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease.

2. Even if the initial diagnosis was WHO grade II glioma, if the pathological diagnosis
for the recurrent disease demonstrate transformation to higher grade (i.e. WHO grade
III or IV) gliomas, patients will be excluded from the eligibility.

3. Concurrent treatment or medications including:

- Radiation therapy

- Chemotherapy

- Interferon

- Allergy desensitization injections

- Growth factors

- Interleukins

- Any investigational therapeutic medication

4. 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.

5. Use of immunosuppressives within 4 weeks prior to study entry or anticipated use of
immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used
peri-operative 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.

6. 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

7. Participants with known addiction to alcohol or illicit drugs.

8. Because patients with immune deficiency are not expected to respond to this therapy,
HIV-positive patients are excluded from the study.

9. Patients who previously participated in UPCI 07-057 are excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Both immunological and safety data will serve as bases to decide whether a larger follow-up study is warranted.

Outcome Time Frame:

4 years

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:

April 2009

Completion Date:

April 2015

Related Keywords:

  • Astrocytoma
  • Oligoastrocytoma
  • Oligodendroglioma
  • cancer
  • brain
  • tumor
  • vaccine
  • Astrocytoma
  • Glioma
  • Oligodendroglioma



UPMC Hillman Cancer Center (University of Pittsburgh Cancer Institute)Pittsburgh, Pennsylvania  15232