Gemcitabine, Docetaxel, Melphalan, and Carboplatin with a Second Transplant in Young Patients with Relapsed Germ Cell Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study at MD Anderson that collects treatment and outcome data from pediatric and adolescent patients receiving GemDMC as part of an autologous stem cell transplant for relapsed/refractory germ cell tumors. The primary goals are to estimate overall survival and progression-free survival after the tandem transplant, with a second CE transplant as needed. The study includes patients up to 21 years old and also analyzes prior GemDMC recipients. Data collected will reflect real-world outcomes in this specific, high-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Irtiza N Sheikh, MD — M.D. Anderson Cancer Center
• Study coordinator: Irtiza N Sheikh, MD
• Email: isheikh1@mdanderson.org
• Phone: (832) 728-9791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.