1800 Williams St., Suite 200 • Denver, CO 80218
Phone 303-388-4876 • Fax 303-336-2193 • Toll Free 1-800-891-7622

URL http://www.rockymountainbmt.com/clinical_trials/Treatment-Of-Germ-Cell-Tumors-With-ICE-High-Dose-Chemotherapy-And-Autologous-Stem-Cell-Rescue-12.html

Treatment Of Germ Cell Tumors With ICE High-Dose Chemotherapy And Autologous Stem Cell Rescue

Principal Investigator: Robert M. Rifkin, MD, FACP

Protocol Number: RMBMT-110


Major Objectives

To evaluate patients with chemosensitive germ cell tumors for disease-free and overall survival following high-dose ICE chemotherapy.

Minor Objectives

To evaluate the short-term and long-term non-hematologic toxicity of the ICE regimen in the outpatient community setting.

Target Population

Patients with poor-risk or relapsed germ cell tumors, who have shown chemosensitivity and who have no conditions that would be unacceptable for high-dose therapy, are eligible for treatment on the protocol. Patients cannot go to high-dose therapy if they are shown to have therapy-refractory disease.

Patient Selection

Inclusion Criteria:

Patients must meet all of the inclusion criteria below.
  1. The patient fulfills the criteria of any one of the three categories (A, B, or C) described below:
    1. The patient is newly diagnosed and has a poor-risk, histologically-documented germ cell tumor that fulfills any one of the following criteria at diagnosis by the international index:20
      • Non-pulmonary visceral metastasis
      • Tumor markers
        • β-fetoprotein >10,000 ng/mL, or
        • β-HCG >50,000 IU/mL (10,000 ng/mL), or
        • LDH >10 times the upper limit of normal
      • Mediastinal germ cell tumor
    2. The patient has not achieved a clinical complete response with initial standard chemotherapy, but:
      • He/she has demonstrated chemosensitivity by achieving at least a partial response to initial chemotherapy, and
      • He/she demonstrates viable carcinoma by either biopsy of the residual mass(es) or continued elevation of tumor markers (note that patients with residual masses and normalization of tumor markers need histological proof of remaining disease).
    3. The patient has a relapsed germ cell tumor.
  2. If the patient has evaluable disease, he/she has achieved either a complete or partial response after four cycles of initial chemotherapy (if 1.A. above, Section 1.4) or salvage chemotherapy (if 1.B. or 1.C above, Section 1.4).
  3. ECOG performance status ≤ 1.
  4. Life expectancy >3 months.
  5. In female patients with child-bearing potential, a negative pregnancy test must be obtained, and the patient must be practicing effective birth control.
  6. WBC >4,000 cells/mL, neutrophil count >1,500 cells/mL, platelet count >100,000 cells/mL at the start of mobilization therapy.
  7. Serum alkaline phosphatase, total bilirubin, and SGOT (or SGPT) <2 times the upper limit of normal.
  8. Serum creatinine <1.5 mg/dL, or creatinine clearance ≥ 60 mL/min.
  9. Left ventricular ejection fraction (LVEF) >45%, by radionuclide cardiac scan (MUGA) or by echocardiography.
  10. FEV1, FVC, and DLCO >50% of predicted.
  11. The patient should have undergone minimal assessment of insurance coverage and be able to demonstrate ability to pay for high-dose chemotherapy with progenitor cell transplant. This is to prevent financial consideration from resulting in withdrawal from the study.
  12. All patients must give written informed consent

Exclusion Criteria:

Patients with any of the following are not eligible:

  1. An active ongoing infection or other medical condition that would prohibit administration of high-dose chemotherapy.
  2. A history of previous malignancy, except non-melanoma skin cancer or in-situ carcinoma of the cervix, unless the patient has been free of disease for >5 years.
  3. A history of heart disease, either angina pectoris requiring nitrate therapy, myocardial infarction within the preceding 6 months, uncontrollable congestive heart failure, uncontrollable hypertension, or major arrhythmia.
  4. Uncontrolled CNS disease.
  5. The patient is HIV- or HBsAg-positive.
  6. A known hypersensitivity to yeast-derived products.