Trial record 1 of 1 for:    NCT01250470
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Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01250470
First received: November 24, 2010
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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


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: laboratory biomarker analysis
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 I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH 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:
  • Incidence of toxicity, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
    The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade.


Secondary Outcome Measures:
  • Immune response, defined as a patient who has responded in either interferon gamma (IFN-γ) enzyme-linked immunosorbent spot (ELISPOT) or multimer assays [ Time Frame: Up to 6 months post-treatment ] [ Designated as safety issue: No ]
    For both assays, time course and magnitude of responses will be plotted and data will be treated using mixed-effect modeling. In addition, Fisher's exact test will be used to determine whether ELISPOT and multimer responses are associated. Additional exploratory analyses will be done as appropriate, and will be data-driven; hypothesis testing is not anticipated. Results will be displayed in plots and tables.


Estimated Enrollment: 9
Study Start Date: September 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (vaccine therapy)
Patients receive montanide ISA-51/survivin peptide vaccine 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
  • Leukine
  • Prokine
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the toxicity profile of the SVN53-67/M57-KLH peptide in Montanide ISA 51 (montanide ISA-51/survivin peptide vaccine) plus with GM-CSF (sargramostim).

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
  • 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 glutamate pyruvate 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
  • HLA-A *02 or HLA-A *03 negative
  • Active infection requiring treatment (including human immunodeficiency virus [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, or standard of care drug therapy within 28 days prior to randomization, or failure to fully recover from hematological effects of prior chemotherapy
  • Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF or magnetic resonance imaging (MRI) contrast agent
  • Life expectancy less than 4 months
  • Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement; participants with mild arthritis requiring nonsteroidal anti-inflammatory drug (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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
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, I 171010, P30CA016056
Study First Received: November 24, 2010
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Oligodendroglioma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on September 16, 2014