Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
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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: 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 I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH in Patients With Survivin-Positive Malignant Gliomas |
- Safety, tolerability, and toxicity (including incidence of regimen-limiting toxicity [RLT]) [ Time Frame: Up to 6 months post-treatment ] [ Designated as safety issue: Yes ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 grading methodology.
- Immune response (rate and magnitude) [ Time Frame: Up to 6 months post-treatment ] [ Designated as safety issue: No ]Including interferon-gamma (IFN)-gamma production by peripheral blood mononuclear cells (PBMC) and pentamer immunoreactivity.
| Estimated Enrollment: | 9 |
| Study Start Date: | October 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:
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 |
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 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] 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 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 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| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Roswell Park 877-275-7724 ASKRPCI@RoswellPark.org | |
| Principal Investigator: Robert A. Fenstermaker | |
| 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: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Brain Neoplasms 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 |
Astrocytoma Glioblastoma Glioma Oligodendroglioma Gliosarcoma 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 May 16, 2013