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Childhood Extracranial Germ Cell Tumor |
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Clinical Trial: Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
This study is currently recruiting patients.
Verified by Institut Gustave Roussy August 2005
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Purpose
This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.
| Condition | Intervention | Phase |
|---|---|---|
| Germ Cell Tumor | Drug: gemcitabine, ifosfamide, cisplatin, G-CSF | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapies
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis
Further Study Details:
Primary Outcomes: Complete response rate
Secondary Outcomes: Toxicity; Progression free survival; Overall survival
Expected Total Enrollment: 37
Secondary Outcomes: Toxicity; Progression free survival; Overall survival
Expected Total Enrollment: 37
Study start: December 2004
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
- Patients older than 16 years
- Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP)
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Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria:
- Testicular primary site
- Prior treatment limited to one program (or 6 or fewer cycles of cisplatin)
- Either a complete response or a partial response with normal serum AFP and HCG
- Relapse documented by rising AFP and/or HCG or by a biopsy
- No previous carcinoma, except basal-cell carcinoma of the skin
- Adequate renal function: measured or calculated creatinine clearance> 60 ml/min
- Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubin < 1.5 fold the upper normal value
- Signed informed consent.
Exclusion Criteria:
- Patients infected by the human immunodeficiency virus (HIV)
- Patients who do not fit inclusion criteria
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00127049
Karim FIZAZI, Dr 33 1 42114559 fizazi@igr.fr
France
Institut Gustave Roussy, Villejuif, 94805, France; Recruiting
Karim FIZAZI, Dr 33 1 42114559 fizazi@igr.fr
Study chairs or principal investigators
Karim FIZAZI, Dr, Principal Investigator, Institut Gustave Roussy
More Information
Study ID Numbers: GIP-TG
Last Updated: August 19, 2005
Record first received: August 3, 2005
ClinicalTrials.gov Identifier: NCT00127049
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 19, 2005
Record first received: August 3, 2005
ClinicalTrials.gov Identifier: NCT00127049
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Childhood Extracranial Germ Cell Tumor Treatment (National Cancer Institute)
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