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Phase I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH in Patients With Survivin-Positive Malignant Gliomas

Phase 1
18 Years
Open (Enrolling)
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Recurrent Adult Brain Tumor

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Trial Information

Phase I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH in Patients With Survivin-Positive Malignant Gliomas


I. To determine the toxicity profile of the SVN53-67/M57-KLH peptide in Montanide ISA 51
plus with GM-CSF.


I. To measure the immune responses induced by SVN53-67/M57-KLH with Montanide ISA 51 with


I. To collect preliminary data on therapeutic efficacy of this combination against malignant


Patients receive montanide ISA-51/survivin peptide vaccine subcutaneously (SC) followed by
sargramostim SC on day 0. Treatment repeats every 2 weeks for 4 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at weeks 16, 20, and 24.

Inclusion Criteria:

- Histologic proof of one of the following: glioblastoma multiforme, anaplastic
astrocytoma, anaplastic oligodendroglioma or anaplastic mixed glioma or anaplastic

- Must have recurrent or progressive disease after standard therapy

- Karnofsky performance status (KPS) greater than or equal to 70

- Human leukocyte antigen (HLA)-A *02 or HLA-A *03 blood cell haplotype documented by
polymerase chain reaction (PCR) analysis or flow cytometry

- Survivin expression on patient's tumor cells documented by immunohistochemistry

- Must be free of systemic infection; subjects with active infections (whether or not
they require antibiotic therapy) may be eligible after complete resolution of the
infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days
before beginning treatment

- White blood count >= 3000/mm^3

- Platelets >= 100,000/mm^3

- Hemoglobin >= 10.0 g/dL

- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =<
2.5 x institutional upper limit of normal (ULN)

- Total bilirubin =< 2.0 mg/dL

- Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)

- Patients of child-bearing potential must agree to use acceptable contraceptive
methods during treatment and for three months after its completion; women must have a
negative serum pregnancy test

- Patients who have had recent cranial surgery are eligible for inclusion, but the
vaccine may not be administered prior to post-operative day 14

- Patient or legal representative must be able to read, understand the investigational
nature of this study and sign an Institutional Review Board approved written informed
consent form prior to receiving any study related procedure

Exclusion Criteria:

- Inability to obtain histologic proof of malignancy or material unavailable for
survivin testing

- Systemic corticosteroid therapy > 12 mg of dexamethasone or equivalent per day at
study entry; patient should be on stable dose

- Human leukocyte antigen (HLA)-A *02 or HLA-A *03 negative

- Active infection requiring treatment (including human immunodeficiency virus [HIV]

- Any medical condition that, in the opinion of the Principal Investigator, would
compromise the patient's ability to participate in the study; this includes chronic
active hepatitis infection, immunodeficiency disease, concurrent neurological
condition or autoimmune disease

- Any of the following: pregnant or nursing women, or women of childbearing potential
or their sexual partners who are unwilling to employ effective contraception
(condoms, diaphragm, birth control pills, injections, intrauterine device, surgical
sterilization, subcutaneous implants or abstinence)

- Concurrent chemotherapy, immunotherapy, radiotherapy, radiosurgery, interferon (e.g.
Intron-A), allergy desensitization injections; growth factors (e.g. Procrit, Aranesp,
Neulasta), interleukins (e.g. Proleukin) or any investigational therapeutic

- Evidence of current drug or alcohol abuse or psychiatric impairment, which in the
investigator's opinion will prevent completion of the protocol therapy or follow-up

- Use of any experimental drug for any reason within the 30 days prior to
randomization, or failure to fully recover from hematological effects of prior

- Known allergy or hypersensitivity to Keyhole Limpet Hemocyanin (KLH), granulocyte
colony-macrophage stimulating factor (GM-CSF) or magnetic resonance imaging (MRI)
contrast agent

- Life expectancy less than 4 months

- Patients with multicentric glioma are excluded

- Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or
autoimmune disorders with visceral involvement; participants with mild arthritis
requiring nonsteroidal anti-inflammatory drugs (NSAID) medications will not be

- Participants who have another cancer diagnosis will be ineligible, except for those
with: squamous cell cancer of the skin without known metastasis, basal cell cancer of
the skin without known metastasis, carcinoma in situ of the breast (ductal carcinoma
in situ [DCIS] or lobular carcinoma in situ [LCIS]), carcinoma in situ of the cervix
and any cancer without distant metastasis that has been treated successfully, without
evidence of recurrence or metastasis for over 5 years

- Unwilling or unable to follow protocol requirements

- Any condition which in the Investigator's opinion deems the patient an unsuitable
candidate to receive study drug

Type of Study:


Study Design:

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

Outcome Measure:

Safety, tolerability, and toxicity (including incidence of regimen-limiting toxicity [RLT])

Outcome Description:

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 grading methodology.

Outcome Time Frame:

Up to 6 months post-treatment

Safety Issue:


Principal Investigator

Robert Fenstermaker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

I 171010



Start Date:

October 2012

Completion Date:

Related Keywords:

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Mixed Glioma
  • Recurrent Adult Brain Tumor
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Glioma
  • Oligodendroglioma
  • Gliosarcoma



Roswell Park Cancer InstituteBuffalo, New York  14263