|
Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma Clinical research trials and Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma clinical trial. Human subjects often get the best healthcare available for their Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma  Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of four different vaccines using melanoma peptides for cytotoxic T cells and helper T cells in treating patients who have metastatic melanoma.
Details: OBJECTIVES: - Compare the cytotoxic T-cell response to each of 12 melanoma peptides restricted by HLA-A1, -A2, or -A3 in patients with metastatic melanoma vaccinated with or without these 12 melanoma peptides and with or without helper peptides. - Compare the helper T-cell response to each of 6 melanoma helper peptides restricted by HLA-DR molecules in patients treated with these vaccinations. - Determine whether the addition of 6 melanoma helper peptides to a vaccine containing multiple class I MHC-restricted peptides augments T-cell responses to the class I restricted peptides in these patients. - Determine, preliminarily, whether booster vaccination maintains immune response in patients treated with these vaccinations. - Compare the rates of clinical response and survival in patients treated with these vaccinations. - Determine, preliminarily, whether cellular immune response correlates with clinical response and survival rates in patients treated with these vaccinations. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to HLA type (HLA-A1 vs HLA-A2 vs HLA-A1 and -A2 vs HLA-A3) and planned sentinel immunized node biopsy (yes vs no). Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1, 2, 3, 5, 6, and 7. - Arm II: Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 1 tetanus helper peptide emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1, 2, 3, 5, 6, and 7. - Arm III: Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1, 2, 3, 5, 6, and 7. - Arm IV: Patients receive 2 injections of multi-epitope peptide vaccine comprising 6HP emulsified with GM-CSF and ISA-51 ID and SC on day 1 of weeks 1, 2, 3, 5, 6, and 7. In all arms, patients continue therapy in the absence of unacceptable toxicity or disease progression necessitating other urgent therapy. At 12 weeks, patients with no evidence of disease progression may receive booster vaccinations according to their randomized treatment arm. Patients receive booster vaccination ID and SC once weekly for 3 weeks. Treatment repeats every 9 weeks for 2 courses, every 12 weeks for 2 courses, and then every 24 weeks for 2 courses in the absence of disease progression. Patients are followed every 3 months for up to 5 years from study randomization. PROJECTED ACCRUAL: A total of 176 patients (44 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV melanoma - Multiple primary melanomas allowed - Metastasis may be from a cutaneous, mucosal, ocular, or unknown primary site - Measurable disease - Must have 2 extremities uninvolved with tumor - Must have at least 2 intact (undissected) axillary and/or inguinal lymph node basins - Prior sentinel node biopsy may not have violated the integrity of a nodal basin - This extremity may still be considered for vaccination - HLA-A1, -A2, or -A3 positive - Prior brain metastases allowed provided all of the following are true: - No more than 3 brain metastases - Metastatic lesions no greater than 2 cm - Surgically resected or treated with gamma-knife or stereotactic radiosurgery - No disease progression in the brain for the past 3 months - More than 30 days since prior steroids PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 - Lymphocyte count at least 700/mm^3 Hepatic - SGOT no greater than 2 times upper limit of normal (ULN) - Bilirubin no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN - Lactic dehydrogenase no greater than 2 times ULN Renal - Creatinine no greater than 1.8 mg/dL Immunologic - No known or suspected major allergy to any components of the study vaccine - No significant detectable infection - No immunosuppression conditions - No prior or concurrent autoimmune disorder requiring cytotoxic or immunosuppressive therapy - Presence of laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms is allowed - Clinical evidence of vitiligo or other forms of depigmenting illness is allowed - Mild arthritis requiring nonsteroidal anti-inflammatory medication is allowed - No autoimmune disorder with visceral involvement Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No recent (within the past year) or concurrent addiction to alcohol or illicit drugs - No other malignancy within the past 5 years except nonmetastatic squamous cell or basal cell skin cancer, ductal or lobular carcinoma in situ of the breast, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior sargramostim (GM-CSF), interferon alfa-2b, or interleukin-2 - No prior vaccination with any of the study peptides Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No concurrent chemotherapy Endocrine therapy - See Disease Characteristics - More than 30 days since prior corticosteroids, including: - Therapeutic doses of oral steroids (e.g., prednisone or dexamethasone) - Topical steroid creams or ointments - Steroid inhalers - No concurrent corticosteroids - No concurrent topical or systemic steroids Radiotherapy - See Disease Characteristics - No prior radiotherapy to measurable disease - At least 4 weeks since prior local control or palliative radiotherapy and recovered - At least 1 week since prior gamma-knife therapy - No concurrent radiotherapy Surgery - See Disease Characteristics - Recovered from prior major surgery - No concurrent surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CraigSlingluff, Study Chair, University of Virginia, Health Sciences Center Cancer Center
Additional Information:
Study ID Numbers: CDR0000335055; ECOG-E1602
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071981
Other Stage 4 Melanoma Studies:
1. Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
2. Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV Melanoma
4. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
5. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Clinical Trials
Other Clinical Trials
Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
|
|
|
|
|
|
|
|
