- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00886457
5-aza-2-deoxycytidine With Pegylated Interferon-alfa 2B: A Phase I Study With Molecular Correlates
19 juli 2011 uppdaterad av: Nevada Cancer Institute
Inhibition of DNA Methylation by 1-hr Infusion of 5-aza-2'-Deoxycytidine (Decitabine) x 10 Days (M-F) With Escalating Doses of Sub-Q Pegylated (PEG) Interferon-alfa 2B (PEG-Intron): A Phase I Study With Molecular Correlates
The purpose of this study is to assess toxicities of a 1-hr infusion of 5-aza-2'-deoxycytidine (decitabine) x 10 days (M-F) plus escalating doses of weekly subcutaneous PEG-interferon-α (PEG-Intron) in patients with metastatic cancer and to identify the maximum tolerated dose of PEG-Intron in this combination.
The pre- and post-treatment samples will be evaluated to identify changes in molecular correlates.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
3
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89135
- Nevada Cancer Institute
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patient must have a biopsy proven cancer, which is metastatic or unresectable, for which (in the opinion of the investigator), no curative or more effective treatment exists.
- Patient must have biopsy accessible tumor and must indicate willingness to undergo biopsies of tumor and normal skin on days 1, 15 and 29.
- Patient must have measurable disease by RECIST criteria by scans performed within 28 days of study enrollment.
- Patient may not have untreated brain metastasis. Patients with previously treated brain metastasis must no longer be receiving steroid therapy for the treatment of their brain metastasis.
- Patient must have a Zubrod performance status of 0 - 2.
- Prior surgery, radiotherapy or chemotherapy is allowed. The patient must not have received chemotherapy, radiotherapy, surgery, biologic therapy or any other investigational drug for any reason within 28 days prior to registration. Concomitant treatment with other anti-cancer agents or radiotherapy, including investigational agents during the course of study treatment is not allowed.
- Patients with extensive pelvic irradiation or prolonged nucleoside analogue pretreatment are excluded due to increased risk for hematologic toxicity.
- Patient must have adequate liver function as defined by a serum bilirubin ≤ 1.5 x the institutional upper limit of normal (IULN), SGOT or SGPT ≤ 2.5 x the institutional upper limit of normal (or ≤ 5 x the institutional upper limit of normal if hepatic metastases is present) obtained within 14 days prior to registration.
- Patient must have an adequate renal function as defined by a serum creatinine ≤ 1.5 x the institutional upper limit of normal, as well as a calculated or measured creatinine clearance (CrCl) ≥ 50 ml/min.
- Patient must have an ANC > 1,500/μl, platelet count > 100,000/μl and hemoglobin > 9 gm/dl (this may be achieved by transfusion if needed) obtained within 14 days prior to registration.
- All patients must be informed of the investigational nature of this study and must provide written acknowledgment of informed consent in accordance with institutional and federal guidelines.
- Both men and women of all races and ethnic groups are eligible for this trial.
- Patients must be ≥ 18 years of age.
Exclusion Criteria:
- Class 3/4 cardiac problems as defined by the New York Heart Association Criteria (e.g., congestive heart failure, myocardial infarction within 2 months of study).
- Severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled infection, e.g., HIV).
- Patient must not be pregnant or nursing mothers because PEG-Intron or decitabine may be harmful to the developing fetus and newborn. Women/men of reproductive potential must agree to use an effective contraceptive method. Women of reproductive potential must have a negative serum pregnancy test within 7 days prior to registration. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Medical or psychological conditions that, in the opinion of the investigator, make the patient unable to tolerate or complete the treatment, or to grant reliable informed consent are not eligible for this study.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I, II, or III cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Decitabine plus PEG Interferon-alfa 2B
3.7 mg/m**2 decitabine plus 0, 0.5, 1.5, 3, or 6 mcg/kg PET-Intron
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Patients will receive decitabine 3.7 mg/m2/day i.v. over 1 hour daily in 10 doses over 2 weeks elapsed time (Monday-Friday) every 28 days plus fixed dose of PEG-Intron (0, 0.5, 1.5, 3 or 6 mcg/kg PEG-Intron) weekly by subcutaneous injection in 28-day cycles .
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Dose limiting toxicity based on CTCAE Version 3.0
Tidsram: Daily for 10 days out of 14, and then weekly every 28 days
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Daily for 10 days out of 14, and then weekly every 28 days
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Genomic DNA methylation and Mage-1 specific promoter methylation in blood cells, tumor and skin
Tidsram: Pretreatment, and then on days 8, 15, 22, and 29
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Pretreatment, and then on days 8, 15, 22, and 29
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Wolfram Samlowski, MD, Nevada Cancer Institute
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2009
Primärt slutförande (Faktisk)
1 augusti 2010
Avslutad studie (Faktisk)
1 oktober 2010
Studieregistreringsdatum
Först inskickad
21 april 2009
Först inskickad som uppfyllde QC-kriterierna
22 april 2009
Första postat (Uppskatta)
23 april 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 juli 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 juli 2011
Senast verifierad
1 juli 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunologiska faktorer
- Interferoner
- Interferon-alfa
- Decitabin
- Interferon alfa-2
- Peginterferon alfa-2b
Andra studie-ID-nummer
- NVCI-0725
- NCI 8224
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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M.D. Anderson Cancer CenterSchering-Plough; Eisai Inc.AvslutadMelanomFörenta staterna
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Philipps University Marburg Medical CenterDeutsche Krebshilfe e.V., Bonn (Germany); AOP Orphan Pharmaceuticals AGAvslutadKronisk myeloid leukemi i remissionFrankrike, Tyskland