- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00081900
A Safety and Efficacy Study of DENSPM in Patients With Liver Cancer Who Are Not Eligible for Surgical Care
9. april 2015 opdateret af: Genzyme, a Sanofi Company
A Phase 1/2 Study of DENSPM (N1, N11-diethylnorspermine) in Patients With Unresectable Hepatocellular Carcinoma
Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM at approximately 5 centers in the United States.
First, we will be trying to determine the highest dose that can be given safely and is well tolerated (this is called the maximally tolerated dose, or the MTD, for short).
Once that is established, we will enroll additional patients to learn more about potential side effects and to see whether DENSPM can slow the growth of HCC tumors.
We also want to learn about the safety of DENSPM.
Many medications used to treat cancer cause side effects (discomforts or illness).
In this study, we want to understand what side effects occur in patients with HCC who are treated with DENSPM.Study was terminated after initial assessment of insufficient data to support clinical benefit in this population.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60612-7323
- University of Illinois- Chicago
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater
- Dana Farber Partners Cancer Care
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232-6307
- Vanderbilt University School of Medicine
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Mary Crowley Medical Research Center
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908-0708
- University of Virginia
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Richmond, Virginia, Forenede Stater, 23249
- McGuire VA Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologically proven HCC, or if the patient is not a medically appropriate candidate for biopsy, then all of the following criteria must be met: A.History of cirrhosis or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)infection. B.A focal liver lesion ≥ 3 cm on CT or MRI with arterial hypervascularization. C.Confirmation of the liver lesion by a second imaging modality (US/ CT/ MRI).D.AFP ≥1000 ng/ml, or ≥ 4000 ng/ml if Hepatitis B surface Ag positive.
- For recurrent HCC, radiographic evidence of progression.
- Not appropriate for curative therapy (surgical resection) or refuses potentially curative therapy
- Measurable disease, defined as having at least one measurable intrahepatic tumor lesion (using Response Criteria in Solid Tumors [RECIST]). Prior therapy is acceptable only if there is documented progression of the selected measurable lesion(s) following completion of the therapy.
- Required laboratory values
- Renal function: serum creatinine ≤1.2mg/dL Hematologic function: leukocyte count ≥1,500/mm3, platelet count ≥50,000/mm3 Hepatic function: transaminases ≤5x upper limit normal (ULN), albumin ≥2.0g/dL, total bilirubin ≤3.5mg/dL Sodium: ≥130mEq/L
- Karnofsky Performance Status of ≥ 60%
- CLIP Score ≤ 3
- If female and of childbearing potential, must use an effective method of contraception
- Willing and able to provide written informed consent
Exclusion Criteria:
- Has received localized therapy (e.g., radiotherapy, RFA, injection therapy, or chemoembolization)within 6 weeks prior to treatment, Day1. Prior local lesion-specific radiotherapy is acceptable only if the treated lesion(s) is/are not the only source of measurable disease or there is documented progression of the treated lesion(s) following completion of the therapy.
- Has received any other systemic therapy for HCC within 3 weeks prior to treatment, Day 1. Prior therapy is acceptable only if there is documented progression following completion of the therapy.
- Has received another investigational therapy within 30 days prior to study entry
- Has any unstable serious or life-threatening medical condition, other than HCC (e.g., unstable angina, other cancer diagnosis with the exception of basal cell carcinoma, or patients with prior malignancy except for adequately treated basal cell carcinoma(s), in situ cervical cancer, or other cancer for which the patient has been disease-free for five or more years)
- Newly noted clinically significant electrocardiogram (ECG) abnormality
- Clinically significant abnormal laboratory result that is not consistent with patient's clinical course
- Active gastrointestinal bleeding resulting in clinically significant hemodynamic changes or a reduction in hemoglobin.
- Active inflammatory bowel disease (IBD) and/or active gastric or duodenal ulcer disease
- Has a history of central nervous system (CNS) metastases, seizure disorder or neurological exam finding suggestive of CNS metastases
- Has Stage B or C liver cirrhosis according to Child-Pugh-Turcotte Classification
- Has ascites refractory to diuretic therapy
- Has any contraindication for MRI procedure
- If female of childbearing potential, has a positive serum HCG
- If female, is lactating
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: DENSPM
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Each patient will receive DENSPM at an initial dose of 30mg/m^2, then escalating to 120mg/m^2, single IV infusion on D1,3,5,8,10,12 of every 28 days as one cycle, planned for 8 cycles if no withdrawn occur
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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To determine the overall safety profile of DENSPM intravenous infusion in patients with unresectable HCC.
Tidsramme: 8 months
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8 months
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To establish the MTD and dose limiting toxicities of DENSPM intravenous infusion in patients with unresectable HCC.
Tidsramme: 8 months
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8 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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To evaluate antitumor response as measured by progression free survival when DENSPM is administered for up to eight 28 day cycles in patients with advanced HCC.
Tidsramme: 8 months
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8 months
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To evaluate the pharmacokinetics of DENSPM in plasma and HCC tissue in patients unresectable HCC.
Tidsramme: 8 months
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8 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2004
Primær færdiggørelse (Faktiske)
1. juli 2007
Studieafslutning (Faktiske)
1. november 2007
Datoer for studieregistrering
Først indsendt
26. april 2004
Først indsendt, der opfyldte QC-kriterier
27. april 2004
Først opslået (Skøn)
28. april 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- Neoplasmer i leveren
- Karcinom
- Carcinom, hepatocellulært
- Antihypertensive midler
- Antineoplastiske midler
- N(1),N(11)-diethylnorspermine
Andre undersøgelses-id-numre
- GD3-165-101
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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