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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00936936
First received: July 8, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to learn if bevacizumab, when given in combination with 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: Bevacizumab
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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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: 50
Study Start Date: June 2009
Estimated Primary Completion Date: June 2016 (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: Bevacizumab/Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC

Drug: Bevacizumab
5 mg/kg intravenous on Day -14 for Cycle #1 and on Day -15 for Cycle #2.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
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: Bevacizumab/Ifosfamide/Carboplatin/Etoposide + PBPC

Drug: Bevacizumab
5 mg/kg intravenous on Day -14 for Cycle #1 and on Day -15 for Cycle #2.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
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

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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. Bleeding diathesis
  12. Hypercoagulable state or thrombophilia
  13. Aspirin (>325 mg/day) use within 10 days before initiation of study treatment.
  14. Ongoing uncontrolled hypertension (>140/90 mm Hg on medication).
  15. Non-healing wound or significant traumatic injury within 30 days before the initiation of study treatment
  16. 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 ClinicalTrials.gov identifier: NCT00936936

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

Locations
United States, Texas
UT 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
Investigators
Study Chair: Yago Nieto, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00936936     History of Changes
Other Study ID Numbers: 2008-0378, NCI-2011-01631
Study First Received: July 8, 2009
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Testis
Relapsed Testicular Cancer
Bevacizumab
Avastin
Anti-VEGF monoclonal antibody
rhuMAb-VEGF
Carboplatin
Paraplatin
Docetaxel
Taxotere
Etoposide
VePesid
Gemcitabine
Gemcitabine Hydrochloride
Gemzar
Ifosfamide
Ifex
Melphalan
Alkeran

Additional relevant MeSH terms:
Testicular Diseases
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Antibodies
Antibodies, Monoclonal
Melphalan
Gemcitabine
Etoposide
Etoposide phosphate
Isophosphamide mustard
Docetaxel
Bevacizumab
Ifosfamide
Carboplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on July 28, 2014