High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Phase 2

Completed

• Conditions: Testicular Cancer

• Registration Number: NCT00936936
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-7-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or female patients, age 12 to 65 years.<br><br> 2. Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the<br> following groups: A) First relapse or progression or second response with an<br> intermediate or high risk according to the Beyer model. B) Second relapse or beyond.<br><br> 3. Adequate renal glomerular and tubular function, as defined by estimated serum<br> creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL, and urinary<br> protein excretion </=500 mg/day.<br><br> 4. Adequate hepatic function, as defined by ALT and AST </=3 x upper limit of normal<br> (ULN); serum bilirubin and alkaline phosphatase </=2 x ULN or considered not<br> clinically significant.<br><br> 5. Adequate pulmonary function with FEV1 (Forced expiratory volume in the first<br> second), FVC (Forced vital capacity) and DLCO (diffusing capacity of the lung for<br> carbon monoxide) >/=50% of predicted, corrected for volume and hemoglobin.<br><br> 6. Adequate cardiac function with LVEF (left ventricular ejection fraction) >/=40%. No<br> uncontrolled arrhythmias or symptomatic cardiac disease.<br><br> 7. Zubrod performance status 0-2.<br><br> 8. A minimum apheresis collection of 5 million CD34+ cells/kg of autologous<br> hematopoietic progenitor cells (AHPC).<br><br> 9. Written informed consent by patients and/ or their parents or legal guardians.<br> Assent for those patients inclusive of ages 12 to 17.<br><br>Exclusion Criteria:<br><br> 1. Growing teratoma syndrome, defined as enlarging tumor masses with normal serum<br> markers during chemotherapy for nonseminomatous GCT.<br><br> 2. Major surgery within 30 days before the initiation of study treatment<br><br> 3. Radiotherapy within 21 days prior to initiation of study treatment<br><br> 4. Prior whole brain irradiation.<br><br> 5. Patients with active central nervous system (CNS) disease, defined as brain or<br> meningeal metastases that are not in complete remission.<br><br> 6. Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV<br> DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).<br><br> 7. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show<br> chronic hepatitis C or positive hepatitis C serology.<br><br> 8. Active infection requiring parenteral antibiotics.<br><br> 9. HIV infection, unless the patient is receiving effective antiretroviral therapy with<br> undetectable viral load and normal CD4 counts<br><br> 10. Patients who have had a previous autologous or allogeneic stem cell transplant in<br> the previous 12 months.<br><br> 11. Positive pregnancy test in a female patient of childbearing potential defined as not<br> post menopausal for twelve months or no previous surgical sterilization.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With 2-year Event-Free Survival (EFS)

Secondary Outcome Measures

Name	Time	Method
Overall Survival