Overview
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Status:
Suspended
Suspended
Trial end date:
2023-12-01
2023-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine comprised of Component A, a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Gary Archer Ph.D.Collaborators:
Annias Immunotherapeutics, Inc.
Pediatric Brain Tumor FoundationTreatments:
Vaccines
Criteria
Inclusion Criteria:1. Patients who are 3 - 35 years old
2. Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV
glioma.
3. Radiology evidence of recurrent medulloblastoma (reMB) or recurrent Grade III and IV
glioma. Patients will be considered for a biopsy or resection of the
recurrent/progressive tumor at the discretion of the treating neurosurgeon and
neuro-oncologist.
4. Brain MRI within one month prior to enrollment.
5. Received prior therapy for their initial diagnosis prior to recurrence/progression or
who are unable to receive radiation therapy due to genetic disorders that put them at
significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome
or NF1 mutation).
6. Patients with neurological deficits should have deficits that are stable for a minimum
of 2 weeks prior to registration.
7. Karnofsky Performance Status (KPS) of ≥ 60% (KPS for > 10 years of age) or Lansky
performance Score (LPS) of ≥ 60 (LPS for ≤ 10 years of age) assessed within 2 weeks
prior to registration. Patients who are unable to walk because of paralysis but who
are up in a wheel chair will be considered ambulatory for the purposes of the
performance score.
8. Bone Marrow:
- ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)*.
- Platelets ≥ 100,000/µl (unsupported)*.
- Hemoglobin > 8 g/dL (may be supported).
9. Renal:
• Serum creatinine ≤ upper limit of institutional normal.
10. Hepatic:
- Bilirubin ≤ 1.5 times upper limit of normal for age.
- SGPT (ALT) ≤ 3 times institutional upper limit of normal for age.
- SGOT (AST) ≤ 3 times institutional upper limit of normal for age.
11. Patients of childbearing or child-fathering potential must be willing to use a
medically acceptable form of birth control, which includes abstinence, while being
treated on this study.
12. Signed informed consent according to institutional guidelines must be obtained prior
to registration.
13. Any prior chemoradiotherapy is allowed.
Exclusion Criteria:
1. Pregnant or need to breast feed during the study period (Negative serum pregnancy test
required).
2. Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F)
illness.
3. Known immunosuppressive disease or human immunodeficiency virus infection.
4. Patients with active renal, cardiac (congestive cardiac failure, myocardial
infarction, myocarditis), or pulmonary disease.
5. Patients receiving concomitant immunosuppressive agents for medical condition.
6. Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent
Grade III or IV glioma.
7. Patients receiving any other investigational drug therapy.
8. Patients on corticosteroids > 0.1 mg/Kg/day (i.e. > the maximum dose of 4 mg/day).
9. Patients with any clinically significant unrelated systemic illness (serious
infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
10. Patients with inability to return for follow-up visits or obtain follow-up studies
required to assess toxicity to therapy.