Return to List

Study Summary
No. 2008-0378:.......Testis......Yago Nieto......Stem Cell Transplantation and Cellular Therapy
.
Study Summary Title
Study Summary
Number:		2008-0378
Study Title:High-dose chemotherapy for poor-prognosis relapsed germ-cell tumors
.
Physician New Patient Referral
Name:Yago NietoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
.
General Information
Disease Group:TestisSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		About 1 month, 100 days, 6 months and 1 year after your second stem cell
transplant. Further evaluations can be done by primary care provider.
Treatment
Agents:		Bevacizumab
Carboplatin
Docetaxel
Etoposide
Gemcitabine
Ifosfamide
Melphalan		Home Care:No home treatment required
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		Three to four weeks, to be repeated in a second cycle
Description/
Intervention:		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.
.
Study Objectives / Outcomes
Primary Endpoint

To derive estimates of the event-free survival (EFS) after high-dose treatment with Bevacizumab-Gemcitabine/Docetaxel/Melphalan/Carboplatin and Bevacizumab-Ifosfamide/Carboplatin/Etoposide.

Secondary Endpoints:

1. To estimate the response rate (RR) and complete response (CR) rate among patients with measurable disease
2. To describe the side effect profiles of Bevacizumab-Gemcitabine/Docetaxel/Melphalan/Carboplatin and Bevacizumab-Ifosfamide/Carboplatin/Etoposide:
- Extramedullary side effects
- Engraftment rate.
3. To estimate the overall survival (OS) after this treatment.
    .
    Study Status Information
    Study Activation / Registration Date:06/02/2009
    IRB Review and Approval Date:03/09/2009
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Open
    Projected Accrual:40
    .
    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    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.
    .
    Links
    Registration Number: NCT00936936
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
    .
    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center