Clinical Trials Design and Development Committee
Chair and Vice-Chair: Sara Stoneham and Robert Huddart
Historically, clinical trials for germ cell tumors (GCTs) have been run independently by separate disease groups—pediatric oncology, gynecologic oncology, and testicular cancer. Separate trials have meant a loss of opportunity to recruit patients more rapidly and a lack of ability to understand the biologic factors that span the presentation of the disease.
One of the major instigations to create MaGIC was to create a multi-disciplinary, collaborative approach to designing trials that span age and gender. MaGIC is not a clinical trial organization. Rather, the goal of MaGIC is to design the needed clinical trials that can then be run through the existing national clinical trial organizations, such as organizations supported by the National Cancer Institute (NCI) in the United States or by Cancer Research UK in the United Kingdom.
The first step toward this goal was to create a risk classification that could be used in jointly designed trials and that would allow comparison of results across trials; the MaGIC risk stratification was published in 2015. Building on this risk stratification, there are currently 3 NCI-funded AYA clinical trials open for GCT patients that are enrolling internationally across age and gender. For more information on these trials, see “active trials” below.
In addition to these active trials, MaGIC is currently designing the next set of clinical trials for GCT patients. Trials under development include: new regimens to be used for pediatric patients in first relapse, less-toxic regimens for metastatic seminoma/dysgerminoma, reducing the use of chemotherapy in immature teratoma, and innovative therapies and trial design for poor-risk patients.
MaGIC’s active trials are open and accruing. Potential collaborators who are interested in becoming involved are invited to contact us at email@example.com to learn more.
Lead organization: Children’s Oncology Group
Trial PI: A. Lindsay Frazier, Dana-Farber Cancer Institute
Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
AGCT1531 is evaluating the outcomes of stage I (low-risk) GCTs that arise in sites other than the testes and that are managed with active surveillance. For standard-risk patients, the trial is a randomized comparison of carboplatin-based vs. cisplatin-based therapy. This randomization was justified by a comparison of pediatric and adolescents outcomes in the UK, which used carboplatin-based therapy vs. the United States, which used cisplatin-based therapy with no significant difference overall or in any subgroup analyses. Results of that comparison were published. Another major objective of both arms of this trial is to evaluate the sensitivity and specificity of serum miRNAs as a serum biomarker for GCTs.
P3BEP / AGCT1532
Lead organization: ANZUP
Trial PI: Peter Grimison, University of Sydney
Accelerated vs Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP)
The purpose of this study is to determine whether “accelerated BEP” given every 2 weeks is more effective than “standard BEP” given every 3 weeks in poor-risk patients. Poor-risk patients are defined in this MaGIC risk stratification. Interval compression of chemotherapy has been shown to increase survival in other cancers, such as Ewing’s sarcoma and breast cancer.
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
This randomized phase III trial compares the outcomes of GCT patients in first relapse using standard-dose combination chemotherapy vs. high-dose combination chemotherapy with stem cell transplant. This trial is open only to males over the age of 14 years.