Recruiting

GemDMC with ASCT

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07662018

Conditions

Prospective Observational Study

Gemcitabine

Docetaxel

Melphalan

Carboplatin

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine (GEM)

Docetaxel

Melphalan

Carboplatin

Study Details

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.

Conditions

Prospective Observational Study

Gemcitabine

Docetaxel

Melphalan

Carboplatin

Study ID

NCT07662018

Start date

Jun 5, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2033

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

Gemcitabine (GEM)

Give by Iv

Docetaxel

Given by Iv

Melphalan

Given by IV

Carboplatin

Given by Iv

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Irtiza N Sheikh, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-23.