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Peptide Vaccine for Glioblastoma Against Cytomegalovirus Antigens (PERFORMANCE)

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ClinicalTrials.gov Identifier: NCT01854099
Recruitment Status : Withdrawn (Investigator decided not to open study.)
First Posted : May 15, 2013
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
American Brain Tumor Association
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation. Patients will then be randomized to one of three arms: 1). standard temozolomide (TMZ)(200mg/m^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard TMZ (200mg/m^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3). dose-intensified TMZ (100 mg./m^2 for 21 days) with vaccine on day 22-24 of each monthly cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ cycles and continue after TMZ cycles until progression or death.

Condition or disease Intervention/treatment Phase
Glioblastoma Biological: PEP-CMV Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 5 Day TMZ with PEP-CMV on Day 6-8
Standard TMZ (200 mg/m2/day x 5 days) with PEP-CMV vaccination on Day 6-8 of each monthly TMZ cycle
Biological: PEP-CMV
500 µg of PEP-CMV vaccine given intradermally on day 6-8 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 1.

Active Comparator: 5 day TMZ with vaccine on day 22-24
Standard TMZ (200 mg/m2/day x 5 days) with vaccination on Day 22-24 of each monthly TMZ cycle
Biological: PEP-CMV
500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 2.

Active Comparator: 21 day TMZ wtih vaccine on day 22-24
Dose-intensified TMZ (100 mg/m2/day x 21 days) with vaccination on day 22-24 of each monthly TMZ cycle
Biological: PEP-CMV
500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (dose-intensified 100 mg/m^2 x 21 days) with group 3.




Primary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]
    To determine the optimal & safe peptide vaccination regimen with TMZ through dose-limiting toxicity (DLT) measurements. The primary safety assessment for DLT will be determined 1 week after the 3rd weekly vaccine. A DLT will be defined as any irreversible Grade 3 toxicity, any Grade 4 toxicity, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression. Initially 6 patients will be accrued to the study (2 per arm) after which accrual will be suspended to review the toxicity experienced by these patients during the first 3 weekly vaccinations. If 0 or 1 of these patients experience DLT, accrual of the remaining patients will commence. Otherwise, modifications of the protocol will be considered before accruing additional patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histopathologically proven newly-diagnosed primary glioblastoma multiforme.
  • The tumor must have a supratentorial component.
  • Patients must be CMV seropositive.
  • Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member or legal representative.
  • For females of child-bearing potential, negative serum pregnancy test 48 hours prior to temozolomide.
  • Women of childbearing potential and male participants must practice adequate contraception.
  • Karnofsky performance status of ≥ 60.
  • Patients must have recovered from the effects of surgery, postoperative infection, and other complications at time of enrollment.

Prior to adjuvant TMZ:

  • Patients must complete radiation therapy (RT) (60.0Gy over 6 weeks) and concomitant TMZ (targeted dose of 75mg/m2/d for <49 days) therapy without significant toxicity that persisted over a duration of 4 weeks. Significant toxicity is defined as one or more of the following observations:

    • Absolute neutrophil count (ANC) < 0.5 x 109/L (Grade 4)
    • Platelet count < 10 x 109/L (Grade 4)
    • Grade 3 or 4 non-hematologic adverse event (AE) (except alopecia, nausea and vomiting unless the patient has failed maximal antiemetic therapy, and fatigue).
  • Documentation of stable or decreasing steroid dose prior to randomization with goal of minimizing steroid use.
  • CBC/differential with adequate bone marrow function as defined below:

    1. ANC, ≥ 1500 cells/mm^3. Platelet count, ≥ 100,000 cells/mm^3.
    2. Hemoglobin ≥ 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
  • Adequate renal function prior to vaccination as defined below:

    a. Blood Urea Nitrogen (BUN) ≤ 25 mg/dl Creatinine ≤ 1.7 mg/dl

  • Adequate hepatic function prior to vaccination as defined below:

    1. Bilirubin ≤ 2.0 mg/dl
    2. ALT ≤ 3 x normal range
    3. AST ≤ 3 x normal range

Exclusion Criteria:

  • Patients did not start RT and TMZ within 5 weeks of surgery.
  • Patients that did not complete 60.0Gy over 6-7 weeks of RT (patients consented prior to completion who do not complete RT will be removed from study and replaced).
  • Progression of disease prior to randomization as defined by RANO.
  • Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)
  • Metastases detected below the tentorium or beyond the cranial vault.
  • Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region (other than TMZ prescribed during radiation for glioblastoma); note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy to the head or neck (except for T1 glottic cancer and that prescribed for GBM ≤60 Gy), resulting in overlap of radiation fields. Radiosurgery is not permitted.
  • Severe, active co-morbidity, defined as follows:

    1. Unstable angina and/or congestive heart failure requiring hospitalization.
    2. Transmural myocardial infarction within the last 6 months.
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of beginning chemoradiation.
    4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of beginning chemoradiation.
    5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
    6. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
    7. Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
    8. Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug.
  • Prior allergic reaction to temozolomide or Keyhole Limpet Hemocyanin (KLH).
  • Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854099


Sponsors and Collaborators
University of Florida
American Brain Tumor Association
Investigators
Principal Investigator: Duane A Mitchell, MD, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01854099     History of Changes
Other Study ID Numbers: PERFORMANCE
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by University of Florida:
Brain Tumor

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Immunologic Factors
Physiological Effects of Drugs