- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00004872
Endostatin in Treating Patients With Advanced Refractory Solid Tumors
Phase I Study of Endostatin in Advanced Cancer Patients
RATIONALE: Endostatin may stop the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have advanced refractory solid tumors.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and Phase II dose of endostatin in patients with advanced refractory solid tumors. II. Determine the qualitative and quantitative nature of the toxicities encountered with endostatin in this patient population. III. Evaluate the basic pharmacokinetics and metabolism of endostatin by measurement of plasma levels by EIA and mass spectrometry in this patient population. IV. Investigate the relationship between pharmacokinetic parameters and toxicity in this patient population. V. Evaluate biologic evidence of angiogenesis inhibition in patients receiving endostatin.
OUTLINE: This is a dose escalation study. Patients receive endostatin IV over 1 hour daily for 28 days, followed by 1 week of rest. Patients receive subsequent courses of daily therapy in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued for this study.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Comprehensive Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory solid tumor for which no curative therapy exists Bidimensionally measurable or evaluable disease accessible to biopsy No brain metastases or primary brain tumors
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: No serious active infection Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: James P. Thomas, MD, PhD, Ohio State University Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000067532
- P30CA014520 (U.S. NIH-stipend/kontrakt)
- WCCC-CO-99910
- NCI-T99-0055
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