Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00470366 : Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
DISEASE CHARACTERISTICS:

- Histologically confirmed germ cell tumor meeting 1 of the following criteria:

- Poor risk, defined by any of the following:

- Testis or retroperitoneal primary site nonseminoma histology without
visceral metastases but with "poor-risk" markers, defined by any of the
following:

- Pretreatment serum lactate dehydrogenase (LDH) > 10 times upper limit
of normal (ULN)

- Pretreatment serum human chorionic gonadotropin (HCG) > 50,000 IU/L

- Pretreatment serum alpha fetoprotein (AFP) > 10,000 ng/mL

- Testis or retroperitoneal primary site nonseminoma histology with one or
more nonpulmonary visceral metastases, including any of the following
(regardless of serum tumor marker values):

- Bone metastases

- Brain metastases

- Hepatic metastases

- Any nonpulmonary metastases (i.e., skin, spleen)

- Mediastinal primary site nonseminoma histology regardless of serum tumor
marker levels or presence/absence of visceral metastases

- Modified intermediate risk, defined by any of the following:

- Testis or retroperitoneal primary site nonseminoma histology with no
nonpulmonary visceral metastases, and with any of the following serum
marker values:

- Pretreatment serum LDH 3.0-10 times ULN

- Pretreatment serum HCG 5,000-50,000 IU/L

- Pretreatment serum AFP 1,000-10,000 ng/mL

- Seminoma histology with one or more nonpulmonary visceral metastases,
including any of the following (regardless of serum tumor marker values or
primary site):

- Bone metastases

- Brain metastases

- Hepatic metastases

- Any nonpulmonary visceral metastases (i.e., skin, spleen)

- Previously untreated disease

- Measurable or evaluable disease

PATIENT CHARACTERISTICS:

- WBC ? 3,000/mm^3

- Platelet count ? 100,000/mm^3

- Creatinine normal or creatinine clearance > 50 mL/min (unless renal dysfunction is
due to tumor obstructing the ureters)

- AST and ALT < 2 times ULN

- Bilirubin < 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent malignancy except for nonmelanoma skin cancer

- No known HIV positivity

- No active infections

PRIOR CONCURRENT THERAPY:

- Recovered from prior surgery

- More than 30 days since prior radiotherapy and recovered (unless evidence of
progressive disease has been documented)

- No prior chemotherapy

- No other concurrent cytotoxic therapy

- Concurrent radiotherapy and surgery allowed for treatment of brain metastases
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00470366      |      Link to official Clinicaltrials.gov listing
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