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

Summary

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

Conditions

• Germ Cell Tumor
• Teratoma
• Choriocarcinoma
• Germinoma
• Mixed Germ Cell Tumor
• Yolk Sac Tumor
• Childhood Teratoma
• Malignant Germ Cell Neoplasm
• Extragonadal Seminoma
• Non-seminomatous Germ Cell Tumor
• Seminoma

Interventions

DRUG

paclitaxel

IV

DRUG

ifosfamide

IV

DRUG

cisplatin

IV

DRUG

pegylated G-CSF

IV

DRUG

G-CSF

IV

DRUG

carboplatin

IV

DRUG

etoposide phosphate

IV

PROCEDURE

stem cell reinfusion

surgical procedure

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• Movember Foundation

  collaborator OTHER

• Institute of Cancer Research (ICR), United Kingdom

  collaborator UNKNOWN

• Cancer Research UK

  collaborator OTHER

• UNICANCER

  collaborator OTHER

• Irish Group CTI

  collaborator UNKNOWN

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Darren Feldman, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-06

Primary Completion

2031-06-01

Completion

2031-06-01

Countries

• United States
• Australia
• Belgium
• Denmark
• France
• Germany
• Ireland
• Italy
• Netherlands
• Spain
• Switzerland
• United Kingdom

Study Locations