A031102: Standard-Dose Combination Chemotherapy Compared to High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Germ cell tumors

Eligibility Overview:

  • 14 years old or older
  • Diagnosis of germ cell tumor (GCT)
  • Previously received 3 to 6 cycles of cisplatin-based chemotherapy
  • No more than one prior line of chemotherapy
  • No prior treatment with high-dose chemotherapy
  1. Brief Summary

    Germ cell tumors are the most common malignancy in adolescent and young adult males in the U.S. and Europe. While early stage disease responds favorably to local therapy or conventional chemotherapy, advanced GCT has a much poorer prognosis. Up to 30 percent of patients with advanced GCT will require salvage treatment. For most of these patients, salvage treatment generally includes one of the following:

    • High-dose chemotherapy (HDCT) with autologous stem cell transplant (ASCT)
    • Conventional-dose chemotherapy (CDCT) incorporating cisplatin, ifosfamide, and either vinblastine (VeIP) or paclitaxel (TIP)

    Current research is inconclusive on which of these approaches is more effective. This randomized, Phase III study will compare the two salvage approaches in treating boys with relapsed or refractory germ cell tumors.

    Primary Objective

    • To compare the overall survival in patients treated with conventional-dose chemotherapy to high-dose chemotherapy plus autologous stem cell transplant as initial salvage treatment of patients with relapsed or refractory germ cell tumors

    Eligibility Criteria

    Inclusion criteria include:

    • 14 years old or older
    • Diagnosis of germ cell tumor (GCT)
    • Previously received 3 to 6 cycles of cisplatin-based chemotherapy
    • No more than one prior line of chemotherapy
    • No prior treatment with high-dose chemotherapy

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

    Collaborating sites in and outside the U.S.

  2. About this study

    Germ cells are part of the body’s normal reproductive system. Sometimes, these cells may later develop into tumors. These are called germ cell tumors and may develop in the ovaries or testicles as well as in other parts of the body. Germ cell tumors may be benign (not cancerous) or malignant (cancerous). Malignant germ cell tumors may be treated with surgery and/or cancer drugs, also known as chemotherapy.

    Some tumors come back after treatment or do not respond to treatment. These patients are usually treated with one of two types of chemotherapy: standard-dose or high-dose. Standard-dose chemotherapy, also known as conventional-dose chemotherapy, generally includes three drugs given together. High-dose chemotherapy usually includes two drugs given at much higher doses than traditional chemotherapy. Both standard-dose chemotherapy and high-dose chemotherapy have been shown to shrink cancer in patients whose cancer has come back after initial chemotherapy treatments. However, doctors do not know if one is better than the other.

    This study will compare the two types of chemotherapy in boys with germ cell tumors that have come back after initial chemotherapy treatment or that did not respond to treatment. The study has two groups: Group 1 and Group 2. A computer will randomly assign boys to one group or the other. Boys in Group 1 will receive standard-dose chemotherapy. Boys in Group 2 will receive high-dose chemotherapy.

    Purpose of this clinical trial

    The main goal of this study is to find out the good and bad effects of standard-dose chemotherapy compared to high-dose chemotherapy.

    Eligibility overview

    • 14 years old or older
    • Diagnosis of germ cell tumor (GCT)
    • Previously received 3 to 6 cycles of cisplatin-based chemotherapy
    • No more than one prior line of chemotherapy
    • No prior treatment with high-dose chemotherapy
  3. A031102  Quick View
    Sponsor  Alliance for Clinical Trials in Oncology
    ClinicalTrials.gov identifier  NCT02375204
    Trial start date March 2015
    Estimated enrollment 420 worldwide (5 at St. Jude)
    Study type Interventional
    Study phase Phase III
    Conditions

    Germ cell tumor

    Ages 14 years old and older
    Principal investigator Alberto Pappo, MD
    Study site St. Jude Children's Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss A031102 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Alberto Pappo, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

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