- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00011973
Chemotherapy in Treating Patients With Advanced Kidney Cancer
A Phase Two Study Of Fenretinide In Renal Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have advanced kidney cancer.
Studieoversigt
Detaljeret beskrivelse
OBJECTIVES:
- Determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide.
- Determine progression-free and overall survival of this patient population treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
OUTLINE: Patients receive oral fenretinide twice a day for 7 days. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 9-21 months.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
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Michigan
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
- University of Pennsylvania Cancer Center
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Texas
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Houston, Texas, Forenede Stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma
Measurable disease
- At least 20 mm with conventional techniques OR
- At least 10 mm with spiral CT scan
No nonmeasurable disease only including:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
No known brain metastases
- History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 2 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide
- No other concurrent uncontrolled illness (e.g., ongoing or active infection)
- No concurrent psychiatric illness or social situation that would preclude study
- History of HIV allowed if no active infection or history of retinitis
- No history of retinal disease, night blindness, or difficulty seeing in the dark
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior biologic therapy allowed
Chemotherapy:
- No more than 1 prior chemotherapy regimen
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- Recovered from prior therapy
- No prior systemic retinoid therapy
- No concurrent antioxidants (e.g., ascorbic acid or vitamin E)
- No other concurrent therapy for renal cell carcinoma
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Ulka N. Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Karcinom
- Neoplasmer, kirtel og epitel
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Beskyttelsesagenter
- Antikarcinogene midler
- Fenretinid
Andre undersøgelses-id-numre
- CDR0000068465
- P30CA022453 (U.S. NIH-bevilling/kontrakt)
- U01CA062487 (U.S. NIH-bevilling/kontrakt)
- WSU-C-2232
- NCI-WSU-910
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