- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00033228
Vaccine Therapy in Treating Patients With Stage IV Melanoma
A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma.
- Determine the safety and tolerability of this drug in these patients.
- Determine the immunological response, as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment, in patients treated with this drug.
- Determine the clinical response, as measured by lactic dehydrogenase levels and radiologic assessment of lesions, in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity. Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment.
Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 10 days after the last dose of study drug.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Arizona
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Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
-
-
California
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Los Angeles, California, Forente stater, 90089
- USC/Norris Comprehensive Cancer Center and Hospital
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-
Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Cancer Research Center at Boston Medical Center
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-
Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Oregon
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Portland, Oregon, Forente stater, 97213-2967
- Earle A. Chiles Research Institute at Providence Portland Medical Center
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV melanoma
Must have tumor tissue available for determining antigen expression
- At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry
- HLA-A2 positive
- No brain metastases unless completely resected or without evidence of disease after treatment
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- WBC at least 3,000/mm3
- Platelet count at least 75,000/mm3
- Hemoglobin at least 9 g/dL
Hepatic:
- SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- Bilirubin no greater than 1.5 times ULN
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal:
- Creatinine no greater than 1.5 times ULN
- Urea no greater than 2.6 times ULN
Other:
- Not pregnant, nursing, or planning to become pregnant within 6 months of treatment completion
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No medical, sociological, or psychological impediments that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- At least 4 weeks since prior immunomodulatory drugs
- No other concurrent immunotherapy
- No concurrent immunomodulatory drugs
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- At least 4 weeks since prior systemic corticosteroids
- No concurrent systemic corticosteroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 4 weeks since prior investigational drugs
- No other concurrent investigational drugs
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cohort 1
The first cohort of 6 patients received 500 ug of Synchrovax SEM plasmid DNA vaccine.
All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group.
The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
|
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
|
Eksperimentell: Cohort 2
The second cohort of 6 patients received 1000 ug of Synchrovax SEM plasmid DNA vaccine.
All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group.
The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
|
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
|
Eksperimentell: Cohort 3
The third cohort of 6 patients received 1500 ug of Synchrovax SEM plasmid DNA vaccine.
The maximum tolerated dose (MTD) was to be determined by the observation of DLT at each dose group.
|
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
|
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.
|
Sekundære resultatmål
Resultatmål |
---|
The secondary objective of the study was to determine the immunological response of patients as measured by tetramer assay and to assess clinical response by LDH levels and radiological assessment of lesions.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Chief Scientific Officer, Mannkind Corporation
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000069252
- CTL-26-35
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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