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Trial record 3 of 18 for:    "Teratoma" | "Anti-Bacterial Agents"

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

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ClinicalTrials.gov Identifier: NCT00453232
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor Biological: bleomycin sulfate Biological: pegfilgrastim Drug: cisplatin Drug: etoposide Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
Study Start Date : August 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009





Primary Outcome Measures :
  1. Toxicity
  2. Feasibility

Secondary Outcome Measures :
  1. Response rate
  2. Progression-free survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453232


Locations
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United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Churchill Hospital
Oxford, England, United Kingdom, OX3 7LJ
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Study Chair: Michael Williams, MD Cambridge University Hospitals NHS Foundation Trust

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ClinicalTrials.gov Identifier: NCT00453232     History of Changes
Other Study ID Numbers: CRCA-CCTC-ACCELERATED-BEP
CDR0000537042 ( Registry Identifier: PDQ (Physician Data Query) )
EUDRACT-2004-000847-79
EU-20713
ISRCTN18505589 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2007
Keywords provided by National Cancer Institute (NCI):
testicular choriocarcinoma and teratoma
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and teratoma
testicular yolk sac tumor and teratoma with seminoma
testicular yolk sac tumor and teratoma
adult teratoma
testicular immature teratoma
testicular mature teratoma
stage III malignant testicular germ cell tumor
testicular choriocarcinoma and seminoma
testicular embryonal carcinoma and seminoma
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma
testicular choriocarcinoma and yolk sac tumor
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
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
recurrent extragonadal germ cell tumor
Additional relevant MeSH terms:
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Teratoma
Antibiotics, Antineoplastic
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Etoposide
Bleomycin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action