A Study of Experimental Accelerated vs Standard Chemotherapy for Germ Cell Tumors (formed from reproductive cells)

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Age: 11 to 45 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Poor-Risk Germ Cell Tumors, germ cell tumors
Type: Drug study, Phase 3
Target:
150 Participants
Investigator:
Description
Standard treatment for advanced germ cell tumors includes three chemotherapy drugs. This is called BEP (Bleomycin, Etoposide, and cisPlatin).

BEP is given with a drug called pegfilgrastim or filgrastim. This makes white blood cells grow. These drugs are given over the course of 3 weeks.

This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen. It will use 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. 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.

The overall goal of this study is to determine whether accelerated BEP will be effective and well-tolerated for patients with advanced GCTs. We don’t yet know if accelerated treatment is helpful in advanced GCTs and we are hoping this study will answer that question.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Age ≥ 11 years and ≤ 45 years on the date of randomisation
  2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
  3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum
  4. Metastatic disease or non-testicular primary
  5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).
  6. Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L
  7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN
  8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan
  9. ECOG Performance Status of 0, 1, 2, or 3
  10. Study treatment both planned and able to start within 14 days of randomisation.
  11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
  12. Able to provide signed, written informed consent

Exclusion criteria:

  1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
  2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration. Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
  3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
  4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin
  5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
  6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
  7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
  8. Known allergy or hypersensitivity to any of the study drugs
  9. 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 The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
Participants will receive treatment on this study for about 3 months. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health every year for about 5 years after you enter this study.
Recruitment period
From Jan. 3, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Germ Cell Tumor

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