Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumors
This study is for the treatment of intermediate and poor-risk germ cell tumors. These tumors are considered ‘advanced’, meaning they are harder to cure and may require more intense therapy to treat.
About
Protocol Description
A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumors
Standard treatment for advanced germ cell tumors includes three chemotherapy drugs called BEP (Bleomycin, Etoposide, and cisPlatin). These drugs are given over the course of 3 weeks. Previous research has been done in studying BEP to improve the outcome of patients with poor‑risk GCTs. One method that was tried is called dose intensification. This method works by giving the dose of chemotherapy drugs over a shorter length of time. Instead of the standard 3- week cycle, patients would receive their treatment in a 2-week cycle. By giving the drugs on a faster, or “accelerated” schedule, the study researchers wanted to see if this would help patients with poor-risk GCTs. The patients on the accelerated therapy in these previous studies did not experience more side effects than would be expected for standard BEP.
This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen using the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental.
COG # AGCT1532
Eligibility Criteria
Inclusion Criteria
- Age ≥ 11 years and ≤ 45 years on the date of randomization.
- Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma) OR exceptionally raised tumor markers (AFP ≥ 1000 ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumor burden, and a need to start therapy urgently.
- Primary arising in testis, ovary, retro-peritoneum, or mediastinum.
- Metastatic disease or non-testicular primary.
- Intermediate or poor prognosis as defined by the IGCCC classification (modified with different LDH criteria or intermediate risk non-seminoma and inclusion of ovarian primaries).
- Must have adequate bone marrow, liver and renal functions
Exclusion Criteria
- Other primary malignancy
- Previous chemotherapy or radiotherapy,
- Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
- Significant co-morbid respiratory disease that contraindicates the use of bleomycin.
- Peripheral neuropathy ≥ Grade 2 or clinically significant sensorineural hearing loss or tinnitus.
- Known allergy or hypersensitivity to any of the study drugs
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
- Presence of any psychological, familial, sociological, or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
Primary Investigator
Dr. Glenn Edwards is the Section Chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's Principal Investigator for Carilion Clinic, and has over 30 years of clinical experience. He is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his Fellowship at Walter Reed Army Medical Center and completed his Internship and Residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, CCRP
Clinical Research Coordinator II
