- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00299689
Phase II Trial of Ontak With Metastatic Melanoma
Phase II Trial of ONTAK With Metastatic Melanoma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a Phase II clinical trial to determine whether administration of ONTAK will result in a significant response rate in patients with metastatic melanoma.
Although the development of effective immunotherapy and the characterization of multiagent chemotherapy regimens have substantially improved in the treatment of metastatic malignant melanoma, the overall results remain dismal with a 6% five year survival rate for stage IV disease. Of the common adult-onset cancers, melanoma is widely held to be the most amenable to immunological intervention.
The primary objective of this study is to determine the response rate and the overall survival of patients with metastatic malignant melanoma treated with two regimens of ONTAK.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40202
- James Graham Brown Cancer Center, Univ. of Louisville
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma of unknown primary are eligible for this study.
Only patients with distant metastases from cutaneous or mucosal melanoma or melanoma of unknown primary are eligible for this study. All patients must fulfill the following criteria:
- Primary tumor must be documented by histopathologic analysis
- Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria (Appendix). Cutaneous lesions measuring at least 1 cm will be considered measurable. Measurements must be documented by radiologic examinations (CT scan, PET scan).
- Disease recurrences occurring greater than five years after the original diagnosis must be biopsy proven.
- Patients with lymph node metastases in multiple lymph node beds who are not amenable to surgical resection will be included in this study. Those patients with involvement of a single lymph node bed are not eligible.
- Liver Function: Patients must have adequate hepatic function documented by a serum bilirubin < 1.5 x the institutional upper limit of normal and liver enzymes (SGOT or SGPT and LDH and alkaline phosphatase) <2X the institutional upper limit of normal within 28 days prior to registration.
- Bone Marrow Function: Patients must have an absolute granulocyte count > 1,500/ul and platelet count > 100,000/ul obtained within 14 days prior to registration.
- Renal Function: Patients must have either a serum creatinine <1.5 mg/dl or a calculated creatinine clearance > 75 cc/min using the following formula:
- Estimated Creatinine Clearance = (140-age) X WT(kg) X 0.85 (if female 0.72) X creatinine (mg/dl) These tests must have been performed within 28 days prior to registration.
- Patients must have a MRI of the head performed within four weeks prior to registration.
- Cardiac Function: Patients must not have a history of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmia, or evidence of prior myocardial infarction on EKG. The qualifying EKG must have been performed prior to study registration, but no earlier than 28 days prior to the definitive surgery. A normal cardiac stress test within 182 days prior to randomization is required for all patients over 50 years old or those with abnormal EKG or any history of cardiac disease.
- Patients must not have evidence of symptomatic pulmonary disease. PFT's within 182 days prior to registration showing a FEV1 > 2.0 liters or >75% of predicted are required for patients over 50 or with history of pulmonary symptoms.
- Patients with known autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids are not eligible for this study. Patients with known AIDS or HIV-1 associated complex or known to be HIV antibody seropositive are not eligible for this study.
- All patients must be 18 years of age or older.
- All patients must have a Zubrod Performance Status of 0 -1
- Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery, or other therapy while on this protocol.
- Pregnant or nursing women may not participate in this trial. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A beta HCG pregnancy test is required within 14 days of registration for women of childbearing potential.
- 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 or II 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention
Single-arm: Ontak
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12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria
Tijdsspanne: 2 weeks after completion of second cycle
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2 weeks after completion of second cycle
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Overall Survival
Tijdsspanne: All cause mortality
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All cause mortality
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Algemene publicaties
- Telang S, Rasku MA, Clem AL, Carter K, Klarer AC, Badger WR, Milam RA, Rai SN, Pan J, Gragg H, Clem BF, McMasters KM, Miller DM, Chesney J. Phase II trial of the regulatory T cell-depleting agent, denileukin diftitox, in patients with unresectable stage IV melanoma. BMC Cancer. 2011 Dec 13;11:515. doi: 10.1186/1471-2407-11-515.
- Rasku MA, Clem AL, Telang S, Taft B, Gettings K, Gragg H, Cramer D, Lear SC, McMasters KM, Miller DM, Chesney J. Transient T cell depletion causes regression of melanoma metastases. J Transl Med. 2008 Mar 11;6:12. doi: 10.1186/1479-5876-6-12.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 076.06
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Kwaadaardig melanoom
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Istituto Clinico HumanitasWervingDISTALE MALIGNANT BILIAIRE OBSTRUCTIEItalië
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National Taiwan University HospitalOnbekend
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The Netherlands Cancer InstituteOnbekendStadium IV huidmelanoom | Oog; MelanomaNederland
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University of AarhusDanish Cancer Society; AmbuFlexVoltooidMelanoma | Kwaliteit van het levenDenemarken
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Herlev HospitalVoltooidMelanoma | HuidkankerDenemarken
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Herlev HospitalVoltooidGeïntegreerde basiswetenschap binnen het instructieontwerp van patroonherkenningstraining (AISC-ISF)Melanoma | HuidkankerDenemarken
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University Medical Center GroningenWervingMelanoma | Hoofd- en nekneoplasmata | MSI-H-kankerNederland
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Vanderbilt-Ingram Cancer CenterWren Laboratories LLCVoltooidMelanomaVerenigde Staten
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Mayo ClinicActief, niet wervendMelanoma | Borstkanker | LymfoedeemVerenigde Staten
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University of UtahVoltooidMelanoma | JongvolwasseneVerenigde Staten
Klinische onderzoeken op Denileukin diftitox
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National Cancer Institute (NCI)BeëindigdLeukemie, volwassen T-celVerenigde Staten
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The University of Texas Health Science Center at...VoltooidEpitheliale eierstokkanker | Eileidercarcinoom | Extraovariële peritoneale kankerVerenigde Staten
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Eisai Inc.Niet meer beschikbaar
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Barbara Ann Karmanos Cancer InstituteEisai Inc.BeëindigdMultipel myeloomVerenigde Staten
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M.D. Anderson Cancer CenterVoltooidLeukemie | Systemische MastocytoseVerenigde Staten
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)VoltooidLymfoomVerenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Voltooid
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Voltooid
-
National Cancer Institute (NCI)VoltooidNierkanker | Melanoom (Huid)Verenigde Staten
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Eisai Inc.VoltooidLymfoom, B-celVerenigde Staten