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Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

Primary Purpose

Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
bleomycin sulfate
pegfilgrastim
cisplatin
etoposide
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring stage III malignant testicular germ cell tumor, testicular choriocarcinoma and seminoma, testicular embryonal carcinoma and seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular seminoma, testicular yolk sac tumor, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, recurrent malignant testicular germ cell tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, adult teratoma, testicular immature teratoma, testicular mature teratoma, recurrent extragonadal germ cell tumor

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Patients must fulfill all of the following criteria for 1 of the following diagnoses:

    • Nonseminoma germ cell tumor (intermediate risk)

      • Testis or retroperitoneal primary
      • Abnormal markers (alpha fetoprotein [AFP] > 1,000 and < 10,000 ng/mL, human chorionic gonadotropin [HCG] > 5,000 and < 50,000 IU/L, lactate dehydrogenase [LDH] > 1.5 times and < 10 times upper limit of normal [ULN])
      • No liver, bone, brain, or other nonpulmonary visceral metastasis
      • Histologic confirmation is not required if AFP or HCG are grossly elevated

    • Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:

      • Mediastinal primary
      • Nonpulmonary visceral metastases
      • Poor markers (AFP > 10,000 ng/mL, HCG > 50,000 IU/L, LDH > 10 times ULN)
      • Histologic confirmation not required if AFP or HCG are grossly elevated

    • Seminoma (intermediate prognosis)

      • Histological confirmation is required
      • Any primary site
      • Nonpulmonary visceral metastases must be present
      • Normal AFP
      • Any HCG
      • Any LDH

    • Surveillance relapse

      • Must fulfill appropriate criteria above according to initial histology

PATIENT CHARACTERISTICS:

  • Neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Must have adequate renal function (creatinine clearance ≥ 60 mL/min)
  • No prior malignancy except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy

Sites / Locations

  • Addenbrooke's Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Saint Bartholomew's Hospital
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Churchill Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • Beatson West of Scotland Cancer Centre

Outcomes

Primary Outcome Measures

Toxicity
Feasibility

Secondary Outcome Measures

Response rate
Progression-free survival

Full Information

First Posted
March 27, 2007
Last Updated
August 6, 2013
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00453232
Brief Title
Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
Official Title
Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.
Detailed Description
OBJECTIVES: Primary Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors. Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients. Secondary Determine the response rate in patients treated with this regimen. Determine the progression-free survival of patients treated with this regimen. OUTLINE: This is a non-randomized, pilot study. Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 2 years. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
Keywords
stage III malignant testicular germ cell tumor, testicular choriocarcinoma and seminoma, testicular embryonal carcinoma and seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular seminoma, testicular yolk sac tumor, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, recurrent malignant testicular germ cell tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, adult teratoma, testicular immature teratoma, testicular mature teratoma, recurrent extragonadal germ cell tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Primary Outcome Measure Information:
Title
Toxicity
Title
Feasibility
Secondary Outcome Measure Information:
Title
Response rate
Title
Progression-free survival

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Patients must fulfill all of the following criteria for 1 of the following diagnoses: Nonseminoma germ cell tumor (intermediate risk) Testis or retroperitoneal primary Abnormal markers (alpha fetoprotein [AFP] > 1,000 and < 10,000 ng/mL, human chorionic gonadotropin [HCG] > 5,000 and < 50,000 IU/L, lactate dehydrogenase [LDH] > 1.5 times and < 10 times upper limit of normal [ULN]) No liver, bone, brain, or other nonpulmonary visceral metastasis Histologic confirmation is not required if AFP or HCG are grossly elevated Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria: Mediastinal primary Nonpulmonary visceral metastases Poor markers (AFP > 10,000 ng/mL, HCG > 50,000 IU/L, LDH > 10 times ULN) Histologic confirmation not required if AFP or HCG are grossly elevated Seminoma (intermediate prognosis) Histological confirmation is required Any primary site Nonpulmonary visceral metastases must be present Normal AFP Any HCG Any LDH Surveillance relapse Must fulfill appropriate criteria above according to initial histology PATIENT CHARACTERISTICS: Neutrophil count ≥ 1,000/mm³ Platelet count ≥ 100,000/mm³ Must have adequate renal function (creatinine clearance ≥ 60 mL/min) No prior malignancy except basal cell carcinoma PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Williams, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

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Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors

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