Active not recruitingPHASE3INTERVENTIONAL

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

This important study is for men with germ cell tumours that have come back or didn't get better with their first treatment. Doctors want to find the best way to treat these tumours. The study compares two types of chemotherapy. One is a standard treatment, and the other is a more intense chemotherapy combined with a stem cell transplant. A stem cell transplant helps replace blood-forming cells that are damaged by strong chemotherapy. Researchers will watch to see which treatment helps patients live longer and keeps the cancer from growing for a longer time. They also want to understand the side effects of each approach.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alliance for Clinical Trials in Oncology

Enrolment target

420

Start

06 Aug 2015

Estimated completion

01 Jun 2031

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

What is this study about?

When germ cell tumours, such as teratomas, seminomas, or mixed germ cell tumours, come back after treatment or don't get better with the first round of chemotherapy, doctors need to find new ways to fight them. This study is designed to compare two main treatment approaches to see which one is more effective and safer for patients in this situation.

One approach is a standard chemotherapy plan using a combination of powerful medicines like paclitaxel, ifosfamide, and cisplatin. These medicines work by attacking cancer cells and stopping them from growing or spreading. The other approach involves a stronger, high-dose chemotherapy regimen, also using drugs like carboplatin and etoposide, combined with a stem cell transplant. This transplant helps your body recover from the high-dose chemotherapy by putting healthy blood-forming cells back into your system.

The main goal is to figure out whether the standard chemotherapy or the more intensive chemotherapy with a stem cell transplant leads to better outcomes for patients, such as living longer and keeping the cancer under control for longer. Researchers will also be looking closely at the side effects of both treatments to ensure patient safety and quality of life.

Key takeaways

This study compares two treatments for germ cell tumours that have returned or didn't respond to initial therapy.
One treatment is standard chemotherapy, the other is high-dose chemotherapy plus a stem cell transplant.
The aim is to find which treatment is safer and more effective.
Participants will be randomly assigned to one of the two treatment groups.
The study involves medicines like paclitaxel, cisplatin, and carboplatin.
It's for men aged 14 and over with specific types of germ cell tumours.

Who may be eligible?

This study is looking for men aged 14 and over who have been diagnosed with a germ cell tumour. Crucially, your tumour must have either come back after previously getting better, or it didn't respond to your first round of chemotherapy treatment.

To join, doctors need to have clear proof of your germ cell tumour, often from a biopsy. You must also show signs that the cancer is active, such as new growths or rising levels of specific markers in your blood. You must have already completed one full course of chemotherapy which included a drug called cisplatin (usually 3 to 6 cycles), and you shouldn’t have had more than one overall line of chemotherapy for your germ cell tumour before this study.

Quick self-check

Are you male and 14 years old or older?
Have you been diagnosed with a germ cell tumour (like teratoma or seminoma)?
Has your tumour come back or not responded to your previous treatment?
Do you have evidence that your cancer is currently active (e.g., new growths or rising blood markers)?
Have you completed one full course of chemotherapy (3-6 cycles) that included cisplatin?
Have you had no more than one overall line of chemotherapy for your germ cell tumour?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be randomly assigned to receive either the standard chemotherapy or the high-dose chemotherapy followed by a stem cell transplant. This means you won’t choose which treatment you get, as it's decided by chance, like flipping a coin. You will have regular appointments for your treatments, which involve taking different medications, and you’ll have blood tests and scans to monitor your health and how the treatment is working. For those receiving a stem cell transplant, there will be additional steps to collect and then reinfuse your own stem cells. The treatments will continue until your cancer progresses or if the side effects become too much. The total duration of your active participation will depend on how you respond to the treatment, but you will be monitored for survival over a longer period.

Potential risks and benefits

Potential benefits of joining this study include receiving treatment that might be more effective than current standard options for your type of cancer. You would also be closely monitored by a healthcare team. However, there are also risks; chemotherapy drugs can cause side effects like nausea, tiredness, hair loss, and a higher risk of infections. The high-dose chemotherapy and stem cell transplant approach can have more severe or long-lasting side effects. It's important to remember that joining a study is always voluntary, and you are free to withdraw at any time without it affecting your usual medical care.

Locations (125)

Children's Hospital of Alabama
Birmingham, United States
UC San Diego Moores Cancer Center
La Jolla, United States
Loma Linda University Medical Center
Loma Linda, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, United States
Kaiser Permanente-Oakland
Oakland, United States
Stanford Cancer Institute Palo Alto
Palo Alto, United States
UCSF Medical Center-Mission Bay
San Francisco, United States
Alfred I duPont Hospital for Children
Wilmington, United States
MedStar Georgetown University Hospital
Washington D.C., United States
University of Florida Health Science Center - Gainesville
Gainesville, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, United States
Nicklaus Children's Hospital
Miami, United States

+113 more sites — see the official record for the full list.

Common questions

What is a germ cell tumour?

Germ cell tumours are a type of cancer that starts in the reproductive cells (germ cells) of the body. They can affect men and sometimes women, and can be found in different parts of the body.

What does 'relapsed or refractory' mean?

Relapsed means the cancer came back after treatment, and refractory means the cancer didn't respond or stop growing with the first treatment you had.

What is a stem cell transplant?

In this study, a stem cell transplant involves giving you strong chemotherapy to kill cancer cells, then returning your own healthy blood-forming cells to help your body recover and make new blood cells.

Will I get to choose my treatment?

No, you will be randomly assigned to one of the two treatment groups (standard chemotherapy or high-dose chemotherapy with transplant). This helps researchers fairly compare the treatments.

What side effects should I expect?

Chemotherapy can cause side effects like feeling sick, tired, losing hair, or having a higher risk of infection. Your healthcare team will discuss all possible side effects with you.