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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07662018
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine (GEM) — DRUG
    Give by Iv
  • Docetaxel — DRUG
    Given by Iv
  • Melphalan — DRUG
    Given by IV
  • Carboplatin — DRUG
    Given by Iv

Study Details

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

Key Dates

Start date
Jun 5, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2033

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Single Arm
    Undergo tandem autologous transplantation with conditioning chemotherapy that includes gemcitabine, docetaxel, melphalan and carboplatin (GemDMC) followed by transplantation with carboplatin and etoposide (CE).

Primary Outcome Measure

safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Irtiza N Sheikh, MD
[email protected]
832-728-9791
Irtiza N Sheikh, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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