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

NCT07662018 | Recruiting FDA Drug

• 2 other identifiers: 2026-0467NCI-2026-04655
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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; Stem Cell Transplantation; Pediatric Relapsed; Refractory Germ

Outcome Measures

Primary Outcomes (1)

• safety and adverse events (AEs).

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

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).

Drug: Gemcitabine (GEM); Drug: Docetaxel; Drug: Melphalan; Drug: Carboplatin

Interventions

Gemcitabine (GEM) DRUG

Give by Iv

Single Arm

Docetaxel DRUG

Given by Iv

Single Arm

Melphalan DRUG

Given by IV

Single Arm

Carboplatin DRUG

Given by Iv

Single Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Gemcitabine; Docetaxel; Melphalan; Carboplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Irtiza N Sheikh, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irtiza N Sheikh, MD

CONTACT

(832) 728-9791; isheikh1@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2033
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

US (1)