Prospective Observational Study of Outcomes After Gemcitabine, Docetaxel, Melphalan, and Carboplatin With Autologous Stem Cell Transplantation in Pediatric Relapsed/Refractory Germ Cell Tumors

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07662018

Enrollment

Registered

2026-06-23

Start date

2026-06-05

Completion date

2033-12-31

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carboplatin, Docetaxel, Gemcitabine, Melphalan, Pediatric Relapsed, Prospective Observational Study, Refractory Germ, Stem Cell Transplantation

Brief summary

To collect information about treatment outcomes in pediatric and adolescent patients with relapsed/refractory germ cells tumors who receive GemDMC with an ASCT.

Detailed description

Primary Objectives To estimate the overall survival (OS) rate and progression free survival (PFS) associated with pediatric and adolescent participants with relapsed/refractory germ cell tumors who receive tandem transplantation with gemcitabine, docetaxel, melphalan, and carboplatin (GemDMC) followed by carboplatin and etoposide (CE) as a second tandem transplantation.

Interventions

DRUGGemcitabine (GEM)

Give by Iv

DRUGDocetaxel

Given by Iv

DRUGMelphalan

Given by IV

DRUGCarboplatin

Given by Iv

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
safety and adverse events (AEs).	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Countries

United States

Contacts

CONTACTIrtiza N Sheikh, MD

isheikh1@mdanderson.org(832) 728-9791

PRINCIPAL_INVESTIGATORIrtiza N Sheikh, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026