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Anaplastic AstrocytomaPhase 1NCT01250470

Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma

A Phase 1 study testing Laboratory Biomarker Analysis, Montanide ISA-51/Survivin Peptide Vaccine and Sargramostim in people with Anaplastic Astrocytoma and Anaplastic Oligoastrocytoma, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Montanide ISA-51/Survivin Peptide Vaccine and Sargramostim
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
5 Sep 2012to 29 May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

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

TERTIARY OBJECTIVES:

  1. 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 12, 16, 20, and 24.

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.

After completion of treatment extension, patients are followed up at 1 month.

Being tested
Laboratory Biomarker Analysis, Montanide ISA-51/Survivin Peptide Vaccine, Sargramostim
Medical subject headings
Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Glioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Montanide ISA-51/Survivin Peptide VaccineDrug

    Given SC

  • SargramostimBiological

    Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine

    Given SC

Study groups in NCT01250470
Study groupRoleWhat they receive
Treatment (vaccine therapy)ExperimentalPatients 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.
Receives: Other: Laboratory Biomarker Analysis; Drug: Montanide ISA-51/Survivin Peptide Vaccine; Biological: Sargramostim

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 30 days post-treatment

Secondary outcomes (1)

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

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

    Measured: Up to 6 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2010 (estimated)
  2. Study start5 Sep 2012
  3. Primary completion29 May 2014
  4. Study completion29 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01250470
Sponsor's protocol ID
I 171010
Other IDs
NCI-2010-02042, I 171010, P30CA016056
Status last verified
Feb 2017
First submitted
24 Nov 2010
Last updated
27 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis, Montanide ISA-51/Survivin Peptide Vaccine and Sargramostim in people with Anaplastic Astrocytoma and Anaplastic Oligoastrocytoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01250470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.

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