Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR in children, adolescent and young adults with diffuse intrinsic pointine glioma (DIPG) or medulloblastoma.

Phase 1

• Conditions: ewly diagnosed Diffuse Intrinsic Pointine Glioma (DIPG) or Medulloblastoma in relapse/progression in children, adolescents and young adults.; MedDRA version: 21.0Level: PTClassification code 10066594Term: Medulloblastoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10080666Term: Diffuse intrinsic pontine gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004838-37-ES
• Lead Sponsor: Fundación de Investigación Biomédica Hospital Niño Jesús

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-11
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

INCLUSION CRITERIA COMMON TO THE TWO COHORTS

1. Patients aged 1 to 21 years.
2. Written informed consent signed by the patient's legal representative and, if applicable, the minor (informed consent in patients 12 years of age or older).
3. Measurable or evaluable disease according to RANO criteria.
4. Appropriate functional status, organic function (renal, hepatic) and hematological values:
o Lanksy and karnofsky functional status =50%. Patients who use a wheelchair due of tumor-associated paralysis will be considered as outpatients for functional status evaluation.
o Haematology function:
• Platelet count =75.000/µL (without support for 3 days)
• Absolute neutrophil count (ANC) =500/ µL (without growth factor for 3 days)
• Hemoglobin = 8 g/dL (Transfusion allowed)
o Liver and renal function
• Glomerular filtration rate (GFR) (estimated by Schwartz ) >60 mL/min/1.73 m2
• Total bilirubin = 1.5 × the upper limit of normal (ULN)
• Transaminases (GOT and GPT) =3 × the upper limit of normal (ULN). = 5 times ULN for patients with hepatic metastasis.
5. Patient able to comply with treatment and schedule of visits and assessments
6. Life expectancy of =8 weeks.
7. Highly effective contraceptive methods (Pearl rate <1) for sexually active males and females of childbearing age (CTFG, Reccomendations related to contraception and pregnancy in clinical trials V 1.1 2020--15). A woman is considered to have reproductive potential, i.e., childbearing, when she has reached menarche through menopause, unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
8. Highly sensitive negative pregnancy test in blood or urine for childbearing females.

INCLUSION CRITERIA COMMON TO THE COHORT A

1. Patient with new DIPG diagnosis (clinical, radiological, or histological in case a biopsy was performed before being included in the study).
2. Not having received previous treatment with radiotherapy or chemotherapy.
3. Patient able to receive radiotherapy

INCLUSION CRITERIA COMMON TO THE COHORT B

1. Patient diagnosed with relapsed and/or refractory medulloblastoma. Patients must have received at least surgery, radiation therapy and chemotherapy as part of standard treatment and have failed these treatments before they can participate in this study.
2. To be recovered to = G1 from the toxic effects according to CTCAE derived from the previous treatments, excluding ototoxicity, alopecia and peripheral neurotoxicity.
Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

EXCLUSION CRITERIA COMMON TO THE TWO COHORTS

1. Previous treatment with Celyvir or AloCelyvir.
2. Known active bacterial, viral, fungal or parasitic infection not controlled
3. Known active Hepatitis B or C virus or VIH infection.
4. If patients are treated with corticosteroids, they should be clinically stable and on stable or tapering doses of steroids for at least one week.
5. To be receiving another anti-cancer treatment not foreseen in this protocol or to anticipate receiving it during the patient's participation in the same concomitant with the experimental treatment
6. Clinically significant or uncontrolled serious active and past systemic diseases that may pose an added risk to the patient

EXCLUSION CRITERIA COMMON TO THE COHORT A

1. Spontaneous massive intratumoral bleeding. Patients with post-operative bleeding (in case of biopsy or surgery) may be included in the study provided that the bleeding is controlled. The same rule applies for other postoperative complications (infection, loss of cerebrospinal fluid, absence of wound closure, subdural collection ...)
2. Patients who have previously received radiotherapy to the brain stem for another malignancy

EXCLUSION CRITERIA COMMON TO THE COHORT B

1. Washout period respect to previous treatments:
- At least two weeks since the last dose of chemotherapy. For patients receiving low-dose metronomic oral chemotherapy, this period is at least one week.
- At least four weeks since the autologous hematopoietic stem cell transplant
- At least two weeks since the last focal radiotherapy or six weeks in case of cranio-spinal radiotherapy.
- At least 2 weeks or 5 half-lifes (whichever occurs first) since the last dose of a biological or investigational treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified