Survivin Vaccine Therapy for Patients With Malignant Gliomas

Survivin Vaccine Therapy for Patients With Malignant Gliomas
This study is not yet open for participant recruitment.
Verified August 2012 by Roswell Park Cancer Institute

First Received on November 24, 2010.  
Last Updated on August 16, 2012  
History of Changes
Sponsor: Roswell Park Cancer Institute
Information provided by (Responsible Party): Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01250470
  Purpose

RATIONALE: Vaccines made from survivin peptide may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy and sargramostim in treating patients with malignant glioma.

Condition Intervention Phase
Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Recurrent Adult Brain Tumor
Drug: Montanide ISA-51/survivin peptide vaccine
Biological: sargramostim
Other: flow cytometry
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH (012410-2) in Patients With Survivin-Positive Malignant Gliomas

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:

  • Toxicity of drug (012140-2) [ Time Frame: Immediately after first dose for 24 weeks, death or progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Immune response [ Time Frame: Baseline, weeks 2, 4, 6,12, 16, 20 and 24 ] [ Designated as safety issue: No ]
  • Therapeutic efficacy [ Time Frame: Baseline, weeks 8 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: August 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: Arm I

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.
Drug: Montanide ISA-51/survivin peptide vaccine

Given SC

Biological: sargramostim

Given SC
Other Names:
  • GM-CSF
  • granulocyte macrophage colony-stimulating factor
  • Leukine
  • Prokine
  • rhu GM-CFS

Other: flow cytometry

Correlative studies

Other: laboratory biomarker analysis

Correlative studies

Other: immunoenzyme technique

Correlative studies
Other Name: immunoenzyme techniques

Detailed Description:

PRIMARY OBJECTIVES: I. To determine the toxicity profile of the SVN53-67/M57-KLH peptide in Montanide ISA 51 plus with GM-CSF. SECONDARY OBJECTIVES: I. To measure the immune responses induced by SVN53-67/M57-KLH with Montanide ISA 51 with GM-CSF. TERTIARY OBJECTIVES: I. To collect preliminary data on therapeutic efficacy of this combination against malignant glioma. OUTLINE: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic proof of one of the following: glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic mixed glioma or anaplastic oligoastrocytoma
  • Karnofsky performance status (KPS) greater than or equal to 70
  • HLA-A *02 or HLA-A *03 blood cell haplotype documented by PCR analysis or flow cytometry
  • Survivin expression by patient’s tumor cells documented by either immunohistochemistry or RT-PCR
  • 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
  • AST(SGOT)/ALT(SGPT) =< 2.5 x institutional ULN
  • Total bilirubin =< 2.0 mg/dL
  • Serum creatinine =< 1.5 x institutional 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
  • Lacking either HLA-A *02 or HLA-A *03 haplotype
  • Active infection requiring treatment (including HIV infection)
  • 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 medication
  • 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 chemotherapy
  • Known allergy or hypersensitivity to Keyhole Limpet Hemocyanin (KLH), granulocyte colony-macrophage stimulating factor (GM-CSF) or 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 NSAID medications will not be excluded
  • 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 (DCIS or 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250470

Locations
United States, New York
Roswell Park Cancer Institute Not yet recruiting
Buffalo, New York, United States, 14263
Contact: AskRPCI     877-275-7724     AskRPCI@RoswellPark.org    
Principal Investigator: Robert A. Fenstermaker            
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Robert Fenstermaker Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01250470    
History of Changes
Other Study ID Numbers: I 171010, NCI-2010-02042
Study First Received: November 24, 2010
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:

Astrocytoma
Brain Neoplasms
Glioblastoma
Glioma
Oligodendroglioma
Gliosarcoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Freund’s Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2012

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