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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: July 8, 2009
Last updated: September 30, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Testicular Cancer
Drug: Gemcitabine
Drug: Docetaxel
Drug: Melphalan
Drug: Carboplatin
Drug: Mesna
Drug: Ifosfamide
Drug: Etoposide
Procedure: Stem Cell Transplant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 2-year Event-Free Survival (EFS) [ Time Frame: 2 Years ]
    Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.

Estimated Enrollment: 67
Study Start Date: June 2009
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cycle # 1

First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)

HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC

Drug: Gemcitabine
1800 mg/m^2 IV over 3 hours on Days -5 to Day -2.
Other Names:
  • Gemcitabine Hydrochloride
  • Gemzar
Drug: Docetaxel
Docetaxel 300 mg/m^2 IV over 2 hours on Day -5.
Other Name: Taxotere
Drug: Melphalan
50 mg/m^2 IV over 15 minutes on Days -4 to Day -2.
Other Name: Alkeran
Drug: Carboplatin

Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2.

Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3.

Other Name: Paraplatin
Procedure: Stem Cell Transplant
Stem cell infusion on Day 0.
Other Names:
  • SCT
  • Hematopoietic progenitor-cell infusion
  • PBPC
Experimental: Cycle #2

Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)

HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC

Drug: Carboplatin

Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2.

Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3.

Other Name: Paraplatin
Drug: Mesna
3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
Other Name: Mesnex
Drug: Ifosfamide
3,000 mg/m^2 IV over 6 hours on Days -6 to -3
Other Name: Ifex
Drug: Etoposide
200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Other Name: VePesid
Procedure: Stem Cell Transplant
Stem cell infusion on Day 0.
Other Names:
  • SCT
  • Hematopoietic progenitor-cell infusion
  • PBPC

  Show Detailed Description


Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 creatinine </= 1.8 mg/dL, and urinary protein excretion </=500 mg/day.
  4. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00936936

Contact: Yago Nieto, MD, PHD 713-792-8750

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77007
Principal Investigator: Yago Nieto, MD, PHD         
United States, Washington
Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Yago Nieto, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00936936     History of Changes
Other Study ID Numbers: 2008-0378
NCI-2011-01631 ( Registry Identifier: NCI CTRP )
Study First Received: July 8, 2009
Last Updated: September 30, 2016

Keywords provided by M.D. Anderson Cancer Center:
Relapsed Testicular Cancer
Anti-VEGF monoclonal antibody
Gemcitabine Hydrochloride

Additional relevant MeSH terms:
Testicular Diseases
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Gonadal Disorders
Etoposide phosphate
Isophosphamide mustard
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017