- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00722098
Comparison Study of Dendritic Cell Vaccine With and Without Cyclophosphamide to Treat Stage IV Melanoma Patients
Melanoma Peptide-Loaded Dendritic Cell Vaccine in HLA-A*0201 Patients With Stage IV Melanoma: A Phase II Randomized Trial to Compare Vaccination With and Without Cyclophosphamide Treatment.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Texas
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Dallas, Texas, Förenta staterna, 75204
- Baylor University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Biopsy-proven metastatic melanoma, Stages M1a, M1b, M1c
- HLA-A*0201 phenotype
- Age: 21-75 years
- ECOG performance status 0-1
- Measurable metastatic melanoma lesions by physical examination or radiographs or scans.
Adequate marrow function:
- White count ≥ 4,000/microliter: Subjects who have recently completed chemotherapy will be allowed study entry with White count ≥ 3,500/microliter
- Hemoglobin ≥ 10.0 gm: Subjects who have recently completed chemotherapy will be allowed study entry with Hemoglobin ≥ 9.0 gm.
- Platelets ≥ 100,000/microliter
Adequate hepatic function:
- Bilirubin ≤ 1.5/mg/dL
- Alkaline phosphatase ≤ 5 times the upper limit of normal
- SGOT ≤ 5 times the upper limit of normal
- SGPT ≤ 5 times the upper limit of normal
Adequate renal function:
- Serum creatinine ≤ 1.5/mg/dL
No active CNS metastatic disease at screening.
- Patients with a history of CNS melanoma lesions must have had lesions resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry.
- The total number of CNS lesions at diagnosis should not have exceeded 3.
- Written informed consent
Exclusion Criteria:
- Patients who have received > 8 cycles of cytotoxic chemotherapy or metastatic melanoma
- Patients who have received any chemotherapy < 4 weeks before the beginning of the trial
- Patients who have received interferon alpha (IFNα-2b) or sargramostim (GM-CSF) < 4 weeks before the beginning of the trial
- Patients who have received high-dose interleukin-2 (IL-2) < 4 weeks before the beginning of the trial
- Patients that have been diagnosed with more than 3 CNS melanoma lesions.
- Patients that have been diagnosed with more than 5 hepatic metastases or any hepatic metastasis > 5 cm.
- Baseline serum LDH > 1.1 times the upper limit of normal
- Patients who are HIV+ (HIV patients are often profoundly immunodeficient because of the viral infection and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. Furthermore, the safety of collecting DCs, loading them with antigen and re-infusing these cells to HIV+ patients has not yet been determined.)
- Pregnancy (Pregnancy is associated with considerable immunosuppression 70 and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. In addition, the safety and tolerability of cell body-loaded DC given subcutaneously is entirely unknown.)
- Patients who have received corticosteroids or other immunosuppressive agents < 4 weeks before beginning the trial
- Patients with active asthma and/or on treatment for asthma
- Patients with angina pectoris
- Patients with congestive heart failure
- Patients with a history of autoimmune disease including lupus erythematosus, rheumatoid arthritis or thyroiditis
- Patients with active infections including viral hepatitis
- Patients with a history of neoplastic disease other than melanoma < 5 years prior to entry on the trial except for patients with carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin. Patients who have any of these two types of cancer and melanoma can be included.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: DC Vaccine & Cyclophosphamide
Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive either CPA 300mg/m2 for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. |
Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive either CPA 300mg/m2 for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.
Andra namn:
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Placebo-jämförare: DC Vaccine & Placebo
Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive saline for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. |
Patients will receive a fixed dose of about ≥15x106 viable dendritic cells per injection. Patients will receive a total of 8 doses of the vaccination with each individual dose being administered at weeks: 0, 2, 4, 6, 10, 14, 18 and 22. Responses will be evaluated and patients with SD, PR or CR may receive 4 more vaccine at 36, 48, 72 and 96 weeks, if there is vaccine available. The vaccine will be injected subcutaneously, in 3 separate injection sites (3.3.ml per site) in the upper and lower extremities. Patients will receive saline for injections administered intravenously over a 2-hour infusion in the outpatient clinic 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Induction of melanoma-specific CD8+T Cell Immunity.
Tidsram: 2 years
|
2 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Rate of objective clinical responses.
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Joseph Fay, M.D., Baylor Institute for Immunology Research: Baylor University Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neuroendokrina tumörer
- Nevi och melanom
- Melanom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antireumatiska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Cyklofosfamid
- Vacciner
Andra studie-ID-nummer
- Baylor IRB #006-123
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