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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Tracking Information
First Submitted Date  ICMJE March 27, 2007
First Posted Date  ICMJE March 28, 2007
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE August 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2007)
  • Toxicity
  • Feasibility
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00453232 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2007)
  • Response rate
  • Progression-free survival
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2007)
  • Response
  • Progression-free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
Official Title  ICMJE Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor
Intervention  ICMJE
  • Biological: bleomycin sulfate
  • Biological: pegfilgrastim
  • Drug: cisplatin
  • Drug: etoposide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 27, 2007)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00453232
Other Study ID Numbers  ICMJE 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) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cambridge University Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael Williams, MD Cambridge University Hospitals NHS Foundation Trust
PRS Account National Cancer Institute (NCI)
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP