Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.

Detailed Description
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OBJECTIVES: Primary Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma. Secondary Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients. Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients. OUTLINE: This is an open-label, multicenter study. Patients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines (IDD-3) to produce the vaccine. Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.

Official Title
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A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages: Stage IIIB or IIIC disease Unresected, in-transit lymph node metastases (N2c or N3) Stage IV disease Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b) No cerebral, bone, or other visceral metastases At least 1 measurable or evaluable lesion Small-volume multiple cutaneous deposits allowed Progressive disease, as defined by 1 of the following criteria: At least 20% increase in size in ≥ 1 measurable or evaluable lesion Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 6 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL (transfusion allowed) Hepatic SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) Lactic dehydrogenase normal No active hepatitis B or C infection Renal Creatinine ≤ 1.5 times ULN Immunologic No history of autoimmune disease Vitiligo allowed No history of immunodeficiency syndrome No active bacterial, viral, or fungal infection within the past 72 hours HIV-1 or -2 negative Human T-cell lymphotrophic virus-I or -II negative Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No contraindication to apheresis No other significant medical or surgical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No prior vaccine therapy with ≥ 1 melanoma antigen or peptide More than 4 weeks since prior biologic therapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy No concurrent chronic systemic corticosteroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 4 weeks since prior investigational products More than 4 weeks since prior chronic systemic immunosuppressive treatment No concurrent medication or treatment regimen that would prelude study participation No other concurrent anticancer treatment No other concurrent immunosuppressive treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Immune response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage III melanoma, stage IV melanoma