Clinical trial · Observational
Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed/Refractory Germ Cell Tumors
NCT07662018CI-TRIAL-00115571recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To collect information about treatment outcomes in pediatric and adolescent patients with relapsed/refractory germ cells tumors who receive GemDMC with an ASCT.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carboplatin | — | UNRESOLVED | — |
| Docetaxel | — | UNRESOLVED | — |
| Gemcitabine | — | UNRESOLVED | — |
| Melphalan | — | UNRESOLVED | — |
| Pediatric Relapsed | — | UNRESOLVED | — |
| Prospective Observational Study | — | UNRESOLVED | — |
| Refractory Germ | — | UNRESOLVED | — |
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine (GEM) | Drug | Gemcitabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Single Arm
- description
- Undergo tandem autologous transplantation with conditioning chemotherapy that includes gemcitabine, docetaxel, melphalan and carboplatin (GemDMC) followed by transplantation with carboplatin and etoposide (CE).
- interventionNames
- Drug: Gemcitabine (GEM)
- Drug: Docetaxel
- Drug: Melphalan
- Drug: Carboplatin
Primary outcomes (1)
- measure
- safety and adverse events (AEs).
- timeFrame
- Through study completion; an average of 1 year
- description
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria * Male or female participants, greater than 1 month of age up to 21 years old. Neonates (birth to 1 month of age) will not be enrolled on this protocol. * Participants with relapsed/refractory seminomatous or nonseminomatous GCT who undergo an autologous stem cell transplantation (ASCT) with conditioning therapy including gemcitabine, docetaxel, melphalan, carboplatin (GemDMC) for germ cell tumors * As part of our analysis, we will also include participants aged 0-21 years old who have previously underwent ASCT with GemDMC * Participants who receive the following regimen: High dose chemotherapy (HDC) course #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin D-6 Admission and start hydration D-5 Gemcitabine 1,500 mg/m2 IV Docetaxel 275 mg/m2 IV D-4 Gemcitabine 1,500 mg/m2 IV Melphalan 20 mg/m2 IV Carboplatin 250 mg/m2 IV D-3 Gemcitabine 1,500 mg/m2 IV Melphalan 20 mg/m2 IV Carboplatin 250 mg/m2 IV D-2 Gemcitabine 1,500 mg/m2 IV Melphalan 20 mg/m2 IV Carboplatin 250 mg/m2 IV D-1 Rest D0 Stem Cell infusion Followed by HDC course #2 consisting of: High-dose course #2: Carboplatin/Etoposide D-6 Admission and start hydration D-5 to -3 Etoposide 750 mg/m2 IV Carboplatin 700 mg/m2 IV D-2 Rest D-1 Rest D0 Stem Cell infusion Exclusion Criteria * Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study
References
Publications (0)
Data not yet available
No reference posted for this study.