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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor

Intervention: bleomycin sulfate (Biological); pegfilgrastim (Biological); cisplatin (Drug); etoposide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Cambridge University Hospitals NHS Foundation Trust

Official(s) and/or principal investigator(s):
Michael Williams, MD, Study Chair, Affiliation: Cambridge University Hospitals NHS Foundation Trust

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Primary Purpose: Treatment

Primary outcome:

Toxicity

Feasibility

Secondary outcome:

Response rate

Progression-free survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

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

Locations and Contacts

Addenbrooke's Hospital, Cambridge, England CB2 2QQ, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England LS9 7TF, United Kingdom

Saint Bartholomew's Hospital, London, England EC1A 7BE, United Kingdom

Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle-Upon-Tyne, England NE4 6BE, United Kingdom

Churchill Hospital, Oxford, England OX3 7LJ, United Kingdom

Edinburgh Cancer Centre at Western General Hospital, Edinburgh, Scotland EH4 2XU, United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, Scotland G11 6NT, United Kingdom

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2004
Last updated: August 6, 2013

Page last updated: August 20, 2015

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