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

• Status: Active, not recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Carboplatin; Docetaxel; Etoposide; Etoposide phosphate; Gemcitabine; Ifosfamide; Isophosphamide mustard; Melphalan

Criteria

Inclusion Criteria:

1. Male or female patients, age 12 to 65 years.

2. 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.

3. Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinineprotein excretion

4. Adequate hepatic function, as defined by ALT and AST(ULN); serum bilirubin and alkaline phosphataseclinically significant.

5. 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.

6. Adequate cardiac function with LVEF (left ventricular ejection fraction) >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

7. Zubrod performance status 0-2.

8. A minimum apheresis collection of 5 million CD34+ cells/kg of autologous hematopoietic progenitor cells (AHPC).

9. Written informed consent by patients and/ or their parents or legal guardians. Assent for those patients inclusive of ages 12 to 17.

Exclusion Criteria:

1. Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT.

2. Major surgery within 30 days before the initiation of study treatment

3. Radiotherapy within 21 days prior to initiation of study treatment

4. Prior whole brain irradiation.

5. Patients with active central nervous system (CNS) disease, defined as brain or meningeal metastases that are not in complete remission.

6. Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).

7. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology.

8. Active infection requiring parenteral antibiotics.

9. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts

10. Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months.

11. Positive pregnancy test in a female patient of childbearing potential defined as not post menopausal for twelve months or no previous surgical sterilization.