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Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor


Phase 2
18 Years
40 Years
Open (Enrolling)
Male
Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor

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Trial Information

Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Safety Issue:

Yes

Principal Investigator

Michael Williams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cambridge University Hospitals NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000537042

NCT ID:

NCT00453232

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor
  • 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
  • Teratoma
  • Neoplasms, Germ Cell and Embryonal

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