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

Purpose

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

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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)
    Give by Iv
  • Drug: Docetaxel
    Given by Iv
  • Drug: Melphalan
    Given by IV
  • Drug: Carboplatin
    Given by Iv

Recruiting Locations

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Irtiza N Sheikh, MD
832-728-9791
isheikh1@mdanderson.org

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Irtiza N Sheikh, MD
(832) 728-9791
isheikh1@mdanderson.org

Detailed Description

Primary Objectives To estimate the overall survival (OS) rate and progression free survival (PFS) associated with pediatric and adolescent participants with relapsed/refractory germ cell tumors who receive tandem transplantation with gemcitabine, docetaxel, melphalan, and carboplatin (GemDMC) followed by carboplatin and etoposide (CE) as a second tandem transplantation.