Phase 2
N=64
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
Testicular Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00936936 ↗Enrolled (actual)
64
Serious AEs
14.1%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With 2-year Event-Free Survival (EFS) — 28; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Docetaxel (Drug); Melphalan (Drug); Carboplatin (Drug); Mesna (Drug); Ifosfamide (Drug); Etoposide (Drug); Stem Cell Transplant (Procedure)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 2-year Event-Free Survival (EFS) |
28; 11 | — |
| SECONDARY Overall Survival |
25; 9 | — |
Summary
The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied.
This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors.
Up to 67 patients will be enrolled in this study.
Eligibility Criteria
Inclusion Criteria
- Male or female patients, age 12 to 65 years.
- Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the following groups: A) First relapse or progression or second response with an intermediate or high risk according to the Beyer model. B) Second relapse or beyond.
- Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine /=50% of predicted, corrected for volume and hemoglobin.
- Adequate cardiac function with LVEF (left ventricular ejection fraction) >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status 0-2.
- A minimum apheresis collection of 5 million CD34+ cells/kg of autologous hematopoietic progenitor cells (AHPC).
- Written informed consent by patients and/ or their parents or legal guardians. Assent for those patients inclusive of ages 12 to 17.
Exclusion Criteria
- Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT.
- Major surgery within 30 days before the initiation of study treatment
- Radiotherapy within 21 days prior to initiation of study treatment
- Prior whole brain irradiation.
- Patients with active central nervous system (CNS) disease, defined as brain or meningeal metastases that are not in complete remission.
- Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
- Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months.
- Positive pregnancy test in a female patient of childbearing potential defined as not post menopausal for twelve months or no previous surgical sterilization.
Data sourced from ClinicalTrials.gov (NCT00936936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.