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


Phase 2
12 Years
65 Years
Open (Enrolling)
Both
Testicular Cancer

Thank you

Trial Information

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


The Study Drugs:

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.

Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material)
of cancer cells, which may cause the cancer cells to die.

Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the
cancer cells to die.

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells
to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by
stopping tumor cells from repairing damage caused by these drugs.

Study Drug Administration:

You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months
apart. One (1) week before your admission to the hospital for the first cycle (about 2 weeks
before the stem cell transplant), you will receive bevacizumab through the CVC over 90
minutes.

Starting on the first day of your hospital stay, you will begin gargling and swishing
Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and
throat sores.

On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4
hours and docetaxel over 2 hours.

On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15
minutes, and carboplatin over 2 hours.

On Day 6, you will not receive any study drugs.

On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.

As part of standard care, you will receive G-CSF (filgrastim) as an injection under your
skin daily, starting 5 days after the transplant, until your blood cell levels return to
normal.

As part of standard mouth care you will be asked to do mouthwashes 4 times a day with
caphosol (artificial saliva) and glutamine.

Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second
cycle of high-dose chemotherapy. One (1) week before your admission to the hospital for this
second cycle (about 2 weeks before the stem cell transplant), you will receive bevacizumab
through the CVC over 90 minutes.

On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over
6 hours, etoposide over 2 hours, and carboplatin over 2 hours.

On Days 5-6, you will not receive any study drugs.

On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.

Study Visits:

About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the
following tests and procedures will be performed:

- To check the status of the disease, you will have CT scans of your chest, abdomen, and
pelvis.

- Blood (about 3 tablespoons) will be drawn for routine tests.

Length of Study:

You will be off study after about 1 year from your second transplant. You will be taken off
study early if the disease gets worse or if you experience any intolerable side effects.

Long-Term Follow-up:

If your doctor thinks it is needed, you may have follow-up visits.

This is an investigational study. Bevacizumab is FDA approved and commercially available
for the treatment of colorectal cancer and breast cancer. Gemcitabine, docetaxel, melphalan,
ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for
the treatment of germ-cell tumors. The use of bevacizumab with gemcitabine, docetaxel,
melphalan, and carboplatin, and with ifosfamide, carboplatin and etoposide is
investigational.

Up to 40 patients will take part in this multicenter study. Up to 40 will be enrolled at MD
Anderson.


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 protein excretion
4. Adequate hepatic function, as defined by ALT and AST (ULN); serum bilirubin and alkaline phosphatase 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year Event-Free Survival (EFS)

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Yago Nieto, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0378

NCT ID:

NCT00936936

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Testicular Cancer
  • 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
  • Testicular Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
Fred Hutchinson Cancer CenterSeattle, Washington  98109