Status:
COMPLETED
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Testicular Cancer
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief 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, doc...
Detailed Description
The Study Drugs: Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die. Docetaxel and etoposide are de...
Eligibility Criteria
Inclusion
- 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 \</= 1.8 mg/dL, and urinary protein excretion \</=500 mg/day.
- Adequate hepatic function, as defined by ALT and AST \</=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \</=2 x ULN or considered not clinically significant.
- Adequate pulmonary function with FEV1 (Forced expiratory volume in the first second), FVC (Forced vital capacity) and DLCO (diffusing capacity of the lung for carbon monoxide) \>/=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
- 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.
Key Trial Info
Start Date :
June 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00936936
Start Date
June 2 2009
End Date
January 11 2024
Last Update
August 26 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77007
2
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109