Status:
WITHDRAWN
Peptide Vaccine for Glioblastoma Against Cytomegalovirus Antigens
Lead Sponsor:
University of Florida
Collaborating Sponsors:
American Brain Tumor Association
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Detailed Description
Eligible patients will be screened and enrolled prior to completion of post-surgical chemoradiation. Final eligibility to remain on study for safety endpoint will occur after completion of chemoradiat...
Eligibility Criteria
Inclusion
- 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:
- ANC, ≥ 1500 cells/mm\^3. Platelet count, ≥ 100,000 cells/mm\^3.
- 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:
- Bilirubin ≤ 2.0 mg/dl
- ALT ≤ 3 x normal range
- AST ≤ 3 x normal range
Exclusion
- 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:
- Unstable angina and/or congestive heart failure requiring hospitalization.
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of beginning chemoradiation.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of beginning chemoradiation.
- 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.
- 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.
- Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- 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.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01854099
Start Date
January 1 2014
End Date
January 1 2014
Last Update
January 14 2014
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