Phase 2: testing Gemcitabine for Recurrent Atypical Teratoid/Rhabdoid Tumor
This is a multi-treatment arm study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC).The study will assess the safety and how well it works of novel therapies and combinatorial strategies for participants with recurrent or progressive ATRT.
Official registry: https://clinicaltrials.gov/study/NCT07447076 · Sabine Mueller, MD, PhD · enrollment listed as 29
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Lumber Puncture, Blood Specimen Collection, or Magnetic resonance imaging (MRI). The registry lists allocation as randomized. This is a multi-treatment arm study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC).The study will assess the safety and how well it works of novel therapies and combinatorial strategies for participants with recurrent or progressive ATRT.
They plan to enroll about 29 people at 3 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Platform Study of Novel Therapies for Children, Adolescents and Young Adults With Recurrent/Progressive Atypical Teratoid Rhabdoid Tumor (ATRT)
Interventions: Lumber Puncture, Blood Specimen Collection, Magnetic resonance imaging (MRI), Gemcitabine, Paxalisib, Tumor Biopsy
Primary outcome (registry wording): Arm A (Phase I): Proportion of participants who experience dose-limiting toxicity (DLT)
Who it is for (from inclusion criteria)
- Ages 1 Year to 39 Years
- In addition to the below, investigators are to refer to arm-specific who can join in the appendix
- Participants must have confirmation of methylation report, co-enrollment on PNOC-030 or sufficient tumor tissue available for methylation-based subgrouping
- Participants must have recurrent or progressive ATRT
- Participants age must be ≥1 and ≤ 39 years at the time of study enrollment. Please refer to arm specific who can join for potential variations in lower age eligibility limit
- Prior Therapy: Participants must have fully recovered from the acute effects of prior anti-cancer therapy, and the following wash-out periods need to be observed prior to enrollment:
- Systemic myelosuppressive therapy: ≥ 21 days after the last dose (42 days for nitrosoureas or mitomycin C)
- Intrathecal/intraventricular chemotherapy: \> 7 days after the last dose
Who the registry excludes
- Evidence of synchronous tumors or other extra-CNS malignancy
- Participants who are receiving any other investigational agents
- Participants who are currently receiving other anti-cancer agents
- Participants with uncontrolled infection or other uncontrolled systemic illness
- Female participants of childbearing potential who are pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy and throughout study treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition as the intended treatment regimen, as detailed in that arm's treatment description
- who can join:
Public study contact (from the registry)
PNOC Operations Office
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- University of California, San Francisco — San Francisco, California (not_yet_recruiting)
- John Hopkins Hospital — Baltimore, Maryland (recruiting)
- Seattle Children's Hospital University of Washington, Seattle — Seattle, Washington (recruiting)
FAQ about this NCT record
Is NCT07447076 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07447076?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07447076?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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