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New treatment option for Recurrent Medulloblastoma
Official title A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)
ClinicalTrials.gov ID: NCT07698899
What this study is testing
What is 25 mCi 177Lu- DTPA-omburtamab?
25 mCi 177Lu- DTPA-omburtamab is an investigational medicine, being studied as a potential treatment for recurrent medulloblastoma.
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
- The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases.
- Phase 1: an early, usually small safety study
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 22
You may be able to join if
- \- Disease type:
- Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid...
- Disease status:
- Patients must have recurrent or refractory disease with CNS parenchymal and/or leptomeningeal disease which has been treated with conventional...
- Prior Therapy: The participant must have recovered from acute toxic effects of prior anti-cancer therapies with the following minimum duration from...
You likely can't join if
- Patients with obstructive or symptomatic communicating hydrocephalus.
- Patients with an uncontrolled life-threatening infection.
- Patients who are pregnant: o A negative pregnancy test is required for all women of childbearing age, and appropriate contraception for 3 months...
- Severe major organ toxicity:
- Cardiac, pulmonary, and gastrointestinal system toxicity should all be \< grade 2
- Patients with grade 4 hearing loss are excluded
See the full eligibility criteria
- \- Disease type:
- Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor...
- Disease status:
- Patients must have recurrent or refractory disease with CNS parenchymal and/or leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists. Measurable or...
- Prior Therapy: The participant must have recovered from acute toxic effects of prior anti-cancer therapies with the following minimum duration from prior therapy:
- Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancertherapy at least 21 days (3 weeks) prior to enrollment or at least 42 days (6 weeks) if prior nitrosourea.
- Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.
- Radiation: Patients must have had their last fraction of:
- Craniospinal irradiation, whole brain radiation, or total body irradiation at least 21 days (3 weeks) prior to study enrollment.
- Focal radiation to areas of symptomatic metastatic disease at least 14 days (2 weeks) prior to study enrollment.
- Stem Cell Transplant (SCT): For autologous SCT, 60 days (≥ 2 months) must have elapsed before study enrollment. Patients who have received an autologous hematopoietic stem cell injection to support non- myeloablative...
- I-MIBG therapy or treatment with other radiopharmaceuticals (neuroblastoma 131 patients): A minimum of 42 days (6 weeks) must have elapsed after I-MIBG therapy before start of protocol therapy.
- Investigational/Biologic Agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days (1...
- Molecular targeted therapies: Patients must complete a washout period from last therapy that is either 7 days (1 week) or 3 half-lives, whichever is longer.
- Patients with neurological deficits should have deficits that are stable for a minimum of 7 days (1 week) prior to enrollment.
- Patients with seizure disorders may be enrolled if seizures are controlled.
- Karnofsky Performance Scale (KPS for \> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within 14 days (2 weeks) prior to study enrollment must be ≥ 50%.
- Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Peripheral absolute neutrophil count (ANC) ≥ 0.5x 109/ L (must not have received G-CSF within 7 days (1 week) prior to enrollment or pegfilgrastim within 14 days (2 weeks) prior to enrollment.
- Platelet count ≥ 75 x 109/ L. Growth factor support (romiplostim or biosimilar) is permitted both prior to and during therapy.
- For patients with neuroblastoma (regardless of marrow disease status) and other solid tumors known bone marrow infiltration from disease: platelet count ≥ 50 x 109/ L (with no platelet transfusion within 7 days prior to...
- to \< 2 years; 0.6, 0.6
- to \< 6 years; 0.8, 0.8 6 to \< 10 years; 1, 1 10 to \< 13 years; 1.2. 1.2 13 to \< 16 years; 1.5, 1.4 ≥ 16 years; 1.7, 1.4
- The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.
- Adequate Liver Function Defined as: - Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (or ≤ 3 x ULN if Gilbert's syndrome) - SGPT (ALT) \< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
- Presence of an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal [VP] shunt or Ommaya reservoir). Patients are not required to have an existing programmable VP shunt or Ommaya at the...
- Note: Patients with an existing intraventricular VP shunt without a programmable component must be willing and able to undergo modification of the shunt.
- Patients may have active malignancy outside the central nervous system but do not immediately require treatment for systemic disease. Neuroblastoma patients with CNS and systemic disease will only receive 1 dose of cRIT...
- Patients may be on standing steroids, as long as the dosage is either stable or decreasing for at least 7 days (1 week) prior to enrollment.
- Human Anti-Mouse Antibody (HAMA) testing will be performed prior to 177Lu-DTPAomburtamab.
- Patients with obstructive or symptomatic communicating hydrocephalus.
- Patients with an uncontrolled life-threatening infection.
- Patients who are pregnant: o A negative pregnancy test is required for all women of childbearing age, and appropriate contraception for 3 months after the last dose of 177Lu-DTPAomburtamab is required during the study...
- Severe major organ toxicity:
- Cardiac, pulmonary, and gastrointestinal system toxicity should all be \< grade 2
- Patients with grade 4 hearing loss are excluded
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.