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
| Arm | Description | Assigned 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). |
|
Recruiting Locations
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
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.