Active — Not RecruitingPhase 1

PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

United States30 participantsStarted 2018-06-29

Plain-language 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.

Who can participate

Age range3 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients who are 3 - 35 years old
✓. Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
✓. 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.
✓. Brain MRI within one month prior to enrollment.
✓. 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).
✓. Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
✓. 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.
✓. Bone Marrow:

What they're measuring

Proportion of patients with unacceptable toxicity

Timeframe: 2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient

Trial details

NCT IDNCT03299309

SponsorDaniel Landi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-27

View on ClinicalTrials.gov More Recurrent Medulloblastoma trials

Plain-language summary

Who can participate

Age range3 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients who are 3 - 35 years old
✓. Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
✓. 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.
✓. Brain MRI within one month prior to enrollment.
✓. 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).
✓. Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
✓. 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.
✓. Bone Marrow:

PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria