Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma

NCT01250470 | Completed Phase 1

• 3 other identifiers: I 171010NCI-2010-02042P30CA016056
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects of vaccine therapy when given together with 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. Colony-stimulating factors, such as sargramostim, may increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy and sargramostim may be a better treatment for malignant glioma.

Conditions

Anaplastic Astrocytoma; Anaplastic Oligoastrocytoma; Anaplastic Oligodendroglioma; Giant Cell Glioblastoma; Glioblastoma; Gliosarcoma; Mixed Glioma; Recurrent Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

• Incidence of toxicity, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4

  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. In addition, descriptive statistics will be utilized to present the toxicity findings in the treatment extension group.

  Up to 30 days post-treatment

Secondary Outcomes (1)

• Immune response, defined as a patient who has responded in either interferon gamma enzyme-linked immunosorbent spot (ELISPOT) or multimer assays

  Up to 6 months post-treatment

Study Arms (1)

Treatment (vaccine therapy)

EXPERIMENTAL

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. TREATMENT EXTENSION: After completion of study treatment, select patients may receive additional doses of Montanide ISA-51/survivin peptide vaccine SC and sargramostim SC. Treatment repeats every 3 months in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Drug: Montanide ISA-51/Survivin Peptide Vaccine; Biological: Sargramostim

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vaccine therapy)

Montanide ISA-51/Survivin Peptide Vaccine DRUG

Given SC

Treatment (vaccine therapy)

Sargramostim BIOLOGICAL

Given SC

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Treatment (vaccine therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 following 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma; Glioblastoma; Gliosarcoma; Glioma; Brain Neoplasms

Interventions

sargramostim; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Robert Fenstermaker

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 30, 2010
• Study Start: September 5, 2012
• Primary Completion: May 29, 2014
• Study Completion: May 29, 2014
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

US (1)