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- Klinische proef NCT00005632
Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer
Vaccination of Prostate Cancer Patients With MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of MUC-1 Glycopeptide Conjugate
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining a vaccine with QS21 may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus immune adjuvant QS21 in treating patients who have prostate cancer.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1 (106) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with prostate cancer expressing MUC-1. II. Determine post-immunization changes in PSA levels and other objective parameters or disease (radionuclide bone scan and/or measurable disease if present) in these patients after receiving this therapy.
OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1 (106) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, 15, and 27 for a total of 6 vaccinations. Patients are followed every 3 months for 1 year or until documented disease progression.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan-Kettering Cancer Center
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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
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer No radiographic evidence of metastatic disease Must show signs of disease progression 3 or more rising PSA values documented, taken at no less than weekly intervals, to greater than 50% above baseline PSA PSA at least 1.0 ng/mL (post prostatectomy) OR 2.0 ng/mL (post radiation) Evaluable disease by serial changes in PSA Progression after primary therapy to include surgery or radiotherapy (with or without neoadjuvant androgen ablation), or intermittent hormonal therapy with noncastrate levels of testosterone (greater than 50 ng/mL) allowed No soft tissue and/or bone disease or androgen independent disease with no evidence of radiographic disease No symptomatic disease or anticipated to be symptomatic within 6 months No active CNS or epidural tumor
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No New York Heart Association class III-IV heart disease Pulmonary: No severe debilitating pulmonary disease Other: No other malignancy within past 5 years except nonmelanoma skin cancer No concurrent infection requiring antibiotics No narcotic dependent pain No positive stool guaiac excluding hemorrhoids No history of documented radiation induced proctitis No allergy to seafood
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since prior changes in hormonal therapy including prednisone or dexamethasone At least 8 weeks since prior suramin OR documented plasma concentration less than 50 mg/mL (replacement doses of hydrocortisone allowed) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy to only measurable lesion Surgery: See Disease Characteristics No concurrent surgery Other: No other concurrent anticancer agents
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: Vaccine
Patients sequentially will receive glycosylated MUC-1-KLH vaccines at 3ug per vaccination.
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Susan Slovin, MD, PhD, Memorial Sloan Kettering Cancer Center
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
- 99-040
- MSKCC-99040
- NCI-G00-1773
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