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Phase I/II Study of Melanoma Vaccine Comprising Autologous Dendritic Cells Pulsed With Tumor Antigen Peptides With or Without Ex Vivo CD40-Ligand Treatment in Patients With HLA-A1 and/or HLA-A2.1 Positive Stage III or IV Melanoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Basic Trial Information
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Phase II, Phase I
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Treatment
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Closed
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Over 18
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ERLANGEN-1490 EU-20232, NCT00053391
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Objectives - Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides treated with vs without ex vivo CD40-ligand, in terms of tumor-specific T-cell response, in patients with HLA-A1 and/or HLA-A2.1 positive stage III or IV melanoma.
- Determine the safety and tolerability of these vaccinations in these patients.
- Determine tumor response and recurrence rates in patients treated with these vaccinations.
Entry Criteria Disease Characteristics:
- Histologically confirmed stage III or IV cutaneous malignant melanoma
- HLA-A1 and/or HLA-A2 expression by serologic HLA typing
- HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells
- No active CNS metastases by CT scan or MRI
Prior/Concurrent Therapy:
Biologic therapy - More than 4 weeks since prior immunotherapy
- No other concurrent immunotherapy
Chemotherapy - More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)
- No concurrent chemotherapy
Endocrine therapy - No concurrent corticosteroids
Radiotherapy - More than 4 weeks since prior radiotherapy
- No prior radiotherapy to the spleen
- Concurrent palliative radiotherapy allowed
Surgery - Recovered from prior surgery
- No prior splenectomy
- No prior organ allograft
- Concurrent surgery on selected metastases (e.g., because of pain or local complications such as compression) allowed
Other - No other concurrent investigational drugs
- No concurrent participation in another clinical trial
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - WBC greater than 2,500/mm3
- Neutrophil count greater than 1,000/mm3
- Lymphocyte count greater than 700/mm3
- Platelet count greater than 75,000/mm3
- Hemoglobin greater than 9 g/dL
- No bleeding disorders
Hepatic - Bilirubin less than 2.0 mg/dL
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal - Creatinine less than 2.5 mg/dL
Cardiovascular - No clinically significant heart disease
Pulmonary - No clinically significant respiratory disease
Immunologic - No active systemic infection
- No immunodeficiency disease
- No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1
- No active autoimmune disease including (but not limited to):
- Lupus erythematosus
- Autoimmune thyroiditis or uveitis
- Multiple sclerosis
- Inflammatory bowel disease
Other - Stable medical condition
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 1 month after study participation
- No organic brain syndrome or psychiatric illness that would preclude study compliance
- No other concurrent active malignancy
- No other concurrent serious illness that would preclude study treatment
- No contraindication to leukapheresis
Expected Enrollment 30A total of 8-30 patients will be accrued for this study within 6-12 months. Outcomes Primary Outcome(s)Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response Safety Tolerability
Secondary Outcome(s)Tumor response Recurrence rates
Outline This is an open-label non-randomized study. Patients are followed for 10 years.
Trial Contact Information
Trial Lead Organizations Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen | | | Gerold Schuler, Protocol chair | | | |
Registry Information | | Official Title | | Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand | | Trial Start Date | | 2002-10-23 | | Registered in ClinicalTrials.gov | | NCT00053391 | | Date Submitted to PDQ | | 2002-10-03 | | Information Last Verified | | 2006-08-15 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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