Health Trials

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

ConditionsProspective Observational StudyGemcitabineDocetaxelMelphalanCarboplatinStem Cell TransplantationPediatric RelapsedRefractory Germ
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Participants who do not or did not receive GemDMC as part of the conditioning regimen for an ASCT are not eligible for this study

Trial design

Treatments tested in this trial

  • Gemcitabine (GEM)
  • Docetaxel
  • Melphalan
  • Carboplatin

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov