- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00002535
Indomethacin Plus Biological Therapy in Treating Patients With Advanced Melanoma
TUMOR INFILTRATING LYMPHOCYTE THERAPY FOR ADVANCED MELANOMA USING IMMUNOMODULATION, A PHASE II STUDY
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Combining biological therapies with indomethacin and cyclophosphamide may kill more tumor cells.
PURPOSE: Phase II trial to compare the effectiveness of indomethacin and biological therapy with or without cyclophosphamide in treating patients who have advanced melanoma that has not responded to previous therapy.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES: I. Determine whether indomethacin given prior to tumor removal can increase the number of tumor infiltrating lymphocytes (TIL) obtained from the tumor specimen of patients with advanced melanoma. II. Determine the efficacy of administering concurrent indomethacin to maximize immune effector cell function in situ during interleukin-2/TIL therapy in these patients. III. Determine the relationship between the phenotypic character of TIL (generated in culture from the patient's tumor) and the response to therapy. IV. Correlate the lytic activity or lymphokine production of TIL (generated in culture from the patient's tumor) with clinical response to therapy. V. Generate and use lymphokine-activated killer (LAK) cells in those patients who do not have TIL available for therapy and evaluate LAK cells in the same manner as TIL.
OUTLINE: Patients with resectable tumors and with adequate generation of TIL are treated on Regimen A; those with unresectable tumors or insufficient TIL are treated on Regimen B. The following acronyms are used: CTX Cyclophosphamide, NSC-26271 IL-2 Interleukin-2 (Cetus), NSC-373364 LAK Lymphokine-Activated Killer Cells TIL Tumor Infiltrating Lymphocytes Regimen A: Prostaglandin Inhibition Therapy plus Biological Response Modifier Therapy. Indomethacin; plus CTX; IL-2-activated TIL; IL-2. Regimen B: Prostaglandin Inhibition Therapy plus Biological Response Modifier Therapy. Indomethacin; plus IL-2-activated LAK; IL-2.
PROJECTED ACCRUAL: Up to 30 patients will be accrued over 3 years. If 0 of the first 10 patients, no more than 1 of the first 15 patients, or no more than 2 of the first 20 patients respond, accrual will cease.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53215
- St. Luke's Medical 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 documented melanoma that is metastatic or unresectable and unresponsive to conventional chemotherapy and/or radiotherapy Measurable or evaluable disease required Measurable disease defined as bidimensionally measurable lesion on physical exam, x-ray, or MRI Evaluable disease defined as: Unidimensionally measurable lesion on x-ray, scan, or photograph Disease assessable by serial chemistries, tumor markers, or nonspecific scans Disease assessable by functional manifestations (e.g., change in performance status, 10% or greater change in weight) Previously irradiated lesion with subsequent disease progression documented Bone-only lesions may be considered evaluable (lytic lesion on x-ray or bone scan should be followed) No metastases on CT or MRI involving more than 50% of the liver No uncontrolled or untreated CNS metastases
PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG 0 or 1 Life expectancy: At least 3 months Hematopoietic: (unless tumor involvement of bone marrow or spleen is documented) WBC at least 3,500/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11.5 g/dL No significant hematologic abnormalities Hepatic: (unless tumor involvement of liver is documented) Bilirubin no greater than 1.6 mg/dL SGOT no greater than 150 U/L PT at least 1.5 times control PTT less than 1.5 times control Renal: (unless tumor involvement of kidney is documented) Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min Calcium no greater than 12 mg/dL No symptomatic hypercalcemia Cardiovascular: No myocardial infarction within 6 months No congestive heart failure No edema No hypotension or hypertension No coronary artery disease No history of arrhythmia No contraindication to the use of pressor agents Pulmonary: FEV1 at least 65% of predicted Other: No significant organ dysfunction No uncontrolled bacterial, viral, or fungal infection No active peptic or duodenal ulcer No psychiatric or seizure disorder No prior solid organ allograft HIV and hepatitis B surface antigen seronegative within 6 months of study entry No second malignancy within 5 years except: Inactive nonmelanomatous skin cancer Carcinoma in situ of the cervix No other serious illness that would limit survival to less than 2 years Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since immunotherapy Chemotherapy: Prior anthracyclines allowed provided no symptomatic heart disease is present More than 4 weeks since chemotherapy (at least 2 weeks, with recovery, if disease progression is documented) More than 6 weeks since nitrosoureas, melphalan, or mitomycin Endocrine therapy: More than 1 week since corticosteroids (except physiological doses for respiratory ailments or adrenal insufficiency) Radiotherapy: More than 4 weeks since radiotherapy (at least 2 weeks, with recovery, if disease progression is documented) Surgery: More than 3 weeks since major surgery (excluding surgery for tumor collection)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: John P. Hanson, MD, St. Luke's Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Melanom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Agenter fra det perifere nervesystem
- Antivirale midler
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Reproduktive kontrolmidler
- Gigthæmmende midler
- Tokolytiske midler
- Aldesleukin
- Cyclofosfamid
- Indomethacin
Andre undersøgelses-id-numre
- STLMC-BRM-93004
- CDR0000078467 (Registry Identifier: PDQ (Physician Data Query))
- NCI-V93-0295
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 .
Kliniske forsøg med Melanom (hud)
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Alma LasersTrukket tilbageSkin ResurfacingForenede Stater
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R2 DermatologyAfsluttet
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Syneron MedicalAfsluttetSkin Resurfacing | RynkereduktionForenede Stater, Canada
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University of Split, School of MedicineAfsluttetSkin Recovery i forskellige humane hudskademodellerKroatien
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National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
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Centre Hospitalier le MansRekruttering
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The First Affiliated Hospital of Dalian Medical...UkendtSår og skader | Trauma | Brud, åben | Skin ExpanderKina
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Integrative Skin Science and ResearchBurt's Bees Inc.RekrutteringAcne | Skin MicroboimeForenede Stater
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National Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Fase IIIC kutan melanom AJCC v7 | Slimhinde melanom | Iris melanom | Fase IIIA kutan melanom AJCC v7 | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Tilbagevendende uveal melanom | Stage IIIA Uveal Melanoma AJCC v7 og andre forholdForenede Stater
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PT. Daewoong InfionEquilab InternationalAfsluttetHudtransplantatar | Split-Thickness Skin Graft (STSG)Indonesien
Kliniske forsøg med aldesleukin
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National Cancer Institute (NCI)AfsluttetMetastatisk melanom | NyrecellekræftForenede Stater
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Cancer Biotherapy Research GroupUkendt
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University of Southern CaliforniaNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor hos voksne, protokolspecifikForenede Stater
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Chiron CorporationAfsluttet
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Blumenthal Cancer Center at Carolinas Medical CenterUkendt
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Cancer Biotherapy Research GroupUkendtLungekræftForenede Stater
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St. Anna KinderkrebsforschungUkendt
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National Cancer Institute (NCI)Afsluttet
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)AfsluttetLymfomForenede Stater
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Beth Israel Deaconess Medical CenterDana-Farber Cancer InstituteAfsluttetMalignt melanomForenede Stater