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Alliance A031102

Trial Overview

Official Title

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

Study Purpose

To determine if giving high dose chemotherapy and having a stem cell transplant will prevent or lengthen the time the time to recurrence when compared to the usual treatment of chemotherapy.  

Diagnosis

Germ Cell Tumor that has grown or returned after initial treatment.

Eligibility

Must have had 3-6 cycles of a cisplatin-based chemotherapy as part of initial treatment.

No prior treatment with high dose cisplatin is allowed.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Chemotherapy: CisplatinPaclitaxelIfosfamideCarboplatinEtoposide
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • Supportive Therapy: Granulocyte-colony stimulating factor (G-CSF). G-CSF helps your body make more white blood cells to help strengthen your immune system. G-CSF is given as an injection under the skin.
  • Stem Cell Transplant
  • ARM A:  Usual chemotherapy and supportive care
  • ARM B: High dose chemotherapy and supportive care followed by stem cell transplant

After completion of study therapy, patients are followed up at 9, 12, 15, 18, 24, 36, 48, and 60 months from the start of treatment.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
A031102
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