Recruiting PHASE2 High Grade Glioma

New treatment option for High Grade Glioma

Official title PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

ClinicalTrials.gov ID: NCT05096481

What this study is testing

What is PEP-CMV?

PEP-CMV is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for high grade glioma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 3 to 39

You may be able to join if

  • for patients with recurrent /progressive medulloblastoma (stratum I)
  • Age: Patients must be ≥3 and ≤39 years of age at the time of study enrollment
  • Diagnosis: Patients must have a diagnosis of medulloblastoma that is recurrent, progressive or refractory. All patients must have histological...
  • Patients must have measurable disease defined as a lesion that can be measured in two perpendicular diameters on MRI.
  • Metastatic Disease: Patients with M+ disease are eligible.

You likely can't join if

  • for all strata:
  • Pregnancy or Breast-Feeding:
  • Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in...
  • Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which...
  • Study Specific:
  • Active infection requiring treatment
See the full eligibility criteria
Who can join
  • for patients with recurrent /progressive medulloblastoma (stratum I)
  • Age: Patients must be ≥3 and ≤39 years of age at the time of study enrollment
  • Diagnosis: Patients must have a diagnosis of medulloblastoma that is recurrent, progressive or refractory. All patients must have histological verification of a medulloblastoma, at original diagnosis or relapse.
  • Patients must have measurable disease defined as a lesion that can be measured in two perpendicular diameters on MRI.
  • Metastatic Disease: Patients with M+ disease are eligible.
  • Performance Status: Karnofsky ≥ 50% for patients \>16 years of age or Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered...
  • Prior Therapy:
  • Radiotherapy: prior radiotherapy requirements Patients must have received prior disease-directed therapy including radiotherapy for their initial diagnosis of medulloblastoma unless patients are less than 4 years of age...
  • Craniospinal irradiation, total body irradiation or radiation to ≥ 50% of pelvis \> 3 months prior to enrollment.
  • Focal irradiation \> 4 weeks prior to enrollment
  • Myelosuppressive anticancer therapy: Patients must have received their last dose of myelosuppressive anticancer therapy at least 21 days prior to enrollment
  • Immunotherapy: Patients must have received their last dose of any immunotherapy agents at least 30 days prior to enrollment
  • Non-myelosuppressive anticancer agents: Patients must have received their last dose of non-myelosuppressive anticancer agents at least 7 days prior to study enrollment.
  • Antibodies: Patients must have received their last dose of any antibodies at least 21 days prior to enrollment.
  • Hematopoietic growth factors: Patients must have received their last dose of hematopoietic growth factors at least 14 days prior to enrollment for a long-acting growth factor (e.g. pegfilgrastim) or 7 days prior to...
  • Autologous stem cell infusion: At least 90 days must have elapsed after an autologous stem cell infusion
  • Organ Function Requirements:
  • Adequate bone marrow function defined as:
  • ANC (Absolute neutrophil count) ≥ 1000/µl.
  • Platelets ≥ 100,000/µl. (may be supported)
  • Hemoglobin \> 8 g/dL. (may be supported)
  • Adequate Renal Function defined as: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or A serum creatinine based on age/gender as follows: Age: Maximum Serum Creatinine (mg/dL)
  • 2 to \< 6 years: 0.8 (Male) 0.8 (Female)
  • 6 to \< 10 years: 1 (Male) 1 (Female)
  • 10 to \< 13 years: 1.2 (Male) 1.2 (Female)
  • 13 to \< 16 years: 1.5 (Male) 1.4 (Female)
  • ≥ 16 years: 1.7 (Male) 1.4 (Female)
  • Adequate Liver Function Defined as
  • Total bilirubin ≤1.5 times institutional ULN
  • AST(SGOT) ≤3 × institutional upper limit of normal
  • ALT(SGPT) ≤3 × institutional upper limit of normal
  • Adequate Neurological Function Defined as
  • Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to enrollment.
  • Patients with current seizure disorders may be enrolled if seizures are well- controlled on antiepileptic therapies.
  • 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 and for three months after drug...
  • Signed informed consent according to institutional guidelines must be obtained prior to enrollment. for Patients with Newly-Diagnosed High-Grade Gliomas (HGG) (stratum II, NOT CURRENTLY ENROLLING) and Newly-Diagnosed...
  • Age: Patients must be ≥3 and ≤39 years of age at the time of study enrollment
  • Diagnosis
  • Stratum II (NOT CURRENTLY ENROLLING): patients must have histologically confirmed, newly-diagnosed HGG (such as anaplastic astrocytoma, glioblastoma, H3K27-altered DMG).
  • Patients with a newly-diagnosed HGG must enroll within 6 weeks of their final dose of standard radiation therapy with or without chemotherapy.
  • Patients with primary spinal cord tumors are eligible
  • Stratum III: Patients with a newly-diagnosed DIPG:
  • Patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation.
  • Patients with brainstem lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of an infiltrating astrocytoma WHO grades II-IV.
  • Metastatic Disease: Patients with M+ disease are eligible.
  • Performance Status: Karnofsky ≥ 50 for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair...
  • Prior Therapy requirements: Patients must have received no prior therapy other than surgery, radiation, chemotherapy during radiotherapy and/or steroids (dexamethasone with goal to wean dexamethasone throughout protocol...
  • Patients with HGG or DIPG are permitted, but not required, to have received chemotherapy during radiation. Bevacizumab is permitted prior to enrollment in patients with DIPG or HGG. Patients must have received their...
  • For HGG patients, Patients must have received radiotherapy at a standard dose of 54-59.4 Gy in 1.8 Gy fractions for approximately 6 weeks with an acceptable variance of 10%. Radiation therapy must have begun no later...
  • For patients with DIPG, Patients must have received radiotherapy at a standard dose of radiotherapy of 54 Gy in 1.8 Gy daily fractions for approximately 6 weeks with an acceptable variance rate of 10%. Radiation therapy...
  • For patients with spinal cord HGG: Patients must have received radiotherapy at a standard dose of 45-54 Gy in 1.8 Gy fractions for approximately 6-7 weeks with an acceptable variance of 10%
  • For patients with metastatic disease: Patients may have received standard dose CSI
  • Organ Function Requirements:
  • Adequate bone marrow function defined as ANC (Absolute neutrophil count) ≥ 1000/µl.
  • Platelets ≥ 100,000/µl. (may be supported)
  • Hemoglobin \> 8 g/dL. (may be supported)
  • Adequate Renal Function defined as: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or A serum creatinine based on age/gender as follows: Age: Maximum Serum Creatinine (mg/dL)
  • 2 to \< 6 years: 0.8 (Male) 0.8 (Female)
  • 6 to \< 10 years: 1 (Male) 1 (Female)
  • 10 to \< 13 years: 1.2 (Male) 1.2 (Female)
  • 13 to \< 16 years: 1.5 (Male) 1.4 (Female)
  • ≥ 16 years: 1.7 (Male) 1.4 (Female)
  • Adequate Liver Function Defined as:
  • Total bilirubin ≤1.5 times institutional ULN
  • AST(SGOT) ≤3 × institutional upper limit of normal
  • ALT(SGPT) ≤3 × institutional upper limit of normal
  • Adequate Neurological Function Defined as: Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment. d. Patients of childbearing or child-fathering potential...
What rules you out
  • for all strata:
  • Pregnancy or Breast-Feeding:
  • Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are...
  • Pregnancy Prevention 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 and for 3...
  • Study Specific:
  • Active infection requiring treatment
  • Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically...
  • Known immunosuppressive disease
  • Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or moderate to severe pulmonary problems generally defined by need for medical intervention (e.g., oxygen...
  • Patients receiving concomitant immunosuppressive agents for medical conditions; inhaled corticosteroids for asthma are allowed.
  • Patients receiving concomitant tumor-directed therapy
  • Patients receiving any other investigational drug therapy.
  • Patients on dexamethasone \> 0.1 mg/Kg/day up to maximum dose of 4 mg/day or equivalent.
  • Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
  • Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
  • Patients at high risk for imminent neurologic decline due to extensive bulk disease, midline shift, or herniation on MRI. These patients should be discussed with the study chairs.

The study team makes the final eligibility decision.

Where it's taking place

  • Aurora, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • St Louis, Missouri, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 3 years to 39 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

ObesityType 2 diabetesType 1 diabetesPrediabetesWeight lossMetabolic syndromeHigh cholesterolHigh triglyceridesHigh blood pressurePCOSHypothyroidismThyroid diseaseGoutFatty liver disease (NAFLD/NASH)Heart failureCoronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.