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Mel 38
*Note: Mel 38 is not a treatment protocol
Evaluation of the Effects of Local GM-CSF-in-adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes
Objectives:
The purpose of this study is to learn what happens to cells at and around the tumor site and in the sentinel lymph node when GM-CSF and adjuvant are injected at the tumor site.
Eligibility: Patients must fit the following criteria:
- Diagnosed with stage I or II melanoma
- Without evidence of metastatic disease
- Between ages 18 and 85 years
- ECOG performance status of 0 or 1
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At least 12 weeks since chemotherapy, interferon, or radiation
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At least 4 weeks since growth factors, interleukins, or corticosteroids
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Not pregnant (female patients must have a negative pregnancy test)
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Laboratory parameters as follows:
ANC, platelets, and Hgb within normal limits
AST, ALT, Bilirubin, Alk phos, and LDH within normal limits
Creatinine up to 1.5 times the upper limits of normal
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Without another cancer diagnosis unless the cancer is a squamous or basal cell skin cancer without metastasis, carinoma in situ of the breast or cervix, or any cancer without distant metastasis that has been treated successfully without evidence of recurrence for over five years
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Without active pulmonary disease
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Without New York Heart Association class III or IV heart disease
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Without systemic autoimmune disease
Outline:
Participants in this study will be randomized to receive an injection with either GM-CSF alone, adjuvant alone, GM-CSF plus adjuvant, or saline alone at their tumor site prior to surgery and removal of the sentinel lymph node. Cells from part of the tumor and lymph node tissue will be studied in the lab to see how they are reacting to the injection.
For information regarding eligibility for our melanoma clinical trials or to
enroll a patient on a trial, please contact our Clinical Research Coordinator,
Johanna Loomba at 434-243-5946 or jjlvd@virginia.edu.
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Mel 44
A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants with Resected Melanoma
Objectives:
The purpose of this trial is to determine whether vaccination with synthetic copies of peptides made by melanoma tumor cells in addition to chemotherapy is safe and will initiate an immune response against cancer cells.
Eligibility: Patients must fit the following criteria.
- Diagnosed with stage IIB, IIC, III, or IV melanoma with no evidence of disease after surgical resection
- Patients with ocular melanoma are excluded
- Age 18 years or older
- Laboratory parameters as follows:
HLA-A1, -A2, or -A3+
HLA-DR1, -DR4, -DR11, -DR13, or -DR15+
ANC > 1000/mm3, platelets > 100,000/mm3, Hgb > 9 g/dL
HGBA1C < 7% (required for patients with diabetes)
AST, ALT, and Bilirubin up to 2.5 times the upper limits of normal
Alkaline phosphatase up to 2.5 times the upper limits of normal
Creatinine up to 1.5 times the upper limits of normal
LDH up to 1.5 times the upper limits of normal
HIV negative, Hepatitis C negative
- ECOG performance status of 0 or 1
- Patients must have at least two intact axillary and/or inguinal lymph node basin
- At least 1 week and less than 6 months since surgery
- At least 4 weeks since chemotherapy, interferon, or radiation
- At least 6 weeks since nitrosoureas
- At least 4 weeks since growth factors, interleukins, corticosteroids, or any other investigational medication
- Patients may not have been vaccinated previously with any of the synthetic peptides included in this protocol
- Patients who have recurred during or after administration of a previous vaccine regimen will be eligible to enroll 12 weeks after the last vaccination
- Not pregnant or breastfeeding
- Without New York Heart Association class III or IV heart disease
- Without another cancer diagnosis unless the cancer is a squamous or basal cell skin cancer without metastasis, carinoma in situ of the breast or cervix, or any cancer without distant metastasis that has been treated successfully without evidence of recurrence for over five years
- Patients with brain metastases may be eligible if the following are true:
1) The total number of brain metastases ever is less than or equal to 3
2) The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry
3) There has been no evident growth of any brain metastasis since treatment
4) No treated brain metastsis is greater than 2 cm in diameter at the time of protocol entry
Outline:
Four different groups will be studied: Groups A, B, C, and D are listed below with a brief outline of what will be received by patients of each group. Vaccines will be administered once a week for six weeks with a one-week break after the third week. Vaccines will also be administered at weeks 12, 26, 39, and 52.
Group A: 12 melanoma peptides plus a tetanus class II MHC-restricted helper peptide in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites.
Group B: Cyclophosphamide administered intravenously. 12 melanoma peptides plus a tetanus class II MHC-restricted helper peptide in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites.
Group C: 12 melanoma peptides plus 6 helper peptides in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites.
Group D: Cyclophosphamide administered intravenously. 12 melanoma peptides plus 6 helper peptides in Montanide adjuvant administered intradermally and subcutaneously at two vaccination sites.
For information regarding eligibility for our melanoma clinical trials or to
enroll a patient on a trial, please contact our Clinical Research Coordinator,
Johanna Loomba at 434-243-5946 or jjlvd@virginia.edu.
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