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This is a study by the National Institutes of Health and AVAX Technologies to determine whether M-Vax is effective in shrinking melanomas that have spread (stage IV). To increase it effectiveness, the M-Vax dosing will be followed by administration of low doses of interleukin-2 (IL2), a marketed drug that is known to stimulate immunity and cause some shrinkage of melanomas. This national study is currently recruiting patients who have Stage IV melanoma and who meet the study's other criteria.
M-Vax + Low Dose Interleukin-2 Versus Placebo Vaccine in Metastatic Melanoma in Patients With Stage IV Melanoma
Purpose
Previous studies suggests that M-Vax, a melanoma vaccine prepared from patients own cancer cells, can stimulated patients' immune system to react against their cancer. AVAX has identified a dose and schedule of administration of M-Vax that work optimally. In this study, AVAX will determine whether M-Vax is effective in shrinkage of melanomas that have spread (stage IV). To increase it effectiveness, M-Vax administration will be followed by administration of low doses of interleukin-2 (IL2), a marketed drug that is known to stimulate immunity and cause some shrinkage of melanomas.
Two-thirds of patients will receive M-Vax + IL2, and one-third will receive a placebo vaccine + IL2. The study is blinded so that neither the patients nor their physicians know which material they are receiving.
To be eligible for this study, patients must have at least one melanoma tumor that can be surgically removed and made into a vaccine. In addition, they must have melanoma that has spread to to the lungs or to soft tissue sites (under the skin, on the surface of the skin, lymph nodes). Eligible patients may have previously received one treatment (for example, chemotherapy) for their melanoma.
Side effects of M-Vax are expected to be mild; the most common is the development of sore pimples at the site of vaccine injections. The low dose IL2 may cause some fatigue and other mild symptoms.
It is expected that 387 patients will be treated in this study.
Eligibility
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Stage IV metastatic melanoma of cutaneous or mucosal origin or without known primary site
- At least one metastatic mass that is surgically resectable, excluding metastases in brain, bowel, or bone
- Successful preparation of a vaccine that meets quality control release criteria
- Following surgery for vaccine preparation, subjects must have at least one measurable metastasis defined by modified RECIST criteria. Non-measurable metastases may also be present. Residual metastases (measurable or non-measurable) must be limited to skin (dermal or subcutaneous), lymph node, or lung, or a combination of these.
- No prior systemic treatment or one prior systemic treatment for metastatic melanoma, not counting post-surgical adjuvant treatment with alpha interferon
- Minimum of one month and maximum of 4 months since the surgery
- Expected survival of at least 6 months
- Karnofsky performance status at least 80
- Signed informed consent
Exclusion Criteria:
Failure to prepare a vaccine that meets all quality control release criteria
- Uveal melanoma
- Post-surgical residual metastases in sites other than specified in 6.1
- Brain metastases, current or past (unless successfully treated at least one year prior to enrollment)
- Hepatic transaminase > 2.5 x ULN
- Total bilirubin > 2.0 mg/Dl
- Creatinine > 2.0 mg/Dl
- Hemoglobin <>
- WBC <>
- Platelet count <>
- Limited field radiotherapy, i.e., limited to recent surgical site, less than 4 weeks prior to first dose of vaccine
- Major field radiotherapy less than 6 months prior to first dose of vaccine
- Any systemic treatment for metastatic melanoma, including chemotherapy, cytokines, or investigational drugs less than 2 months prior to first dose of vaccine
- Previous administration of M-Vax
- Prior splenectomy
- Administration of systemic steroids less than 4 weeks prior to first dose of vaccine. Topical steroids are allowed during the study, provided these are not applied to vaccine injection sites. Inhaled aerosol steroids also are allowed during the study.
- Administration of immunosuppressive drugs less than 4 weeks prior to first dose of vaccine
- Administration of antitubercular drugs (e.g., isoniazid, rifampin, streptomycin) less than 4 weeks prior to first dose of vaccine
- HIV 1/2 positive by ELISA, confirmed by Western blot
- Hepatitis B surface antigen or hepatitis C antibody positive
- Other malignancy within 5 years except: curatively treated non-invasive melanoma, non-melanomatous skin cancer, carcinoma in situ of the uterine cervix, or early stage (stage A or B1) prostate cancer
- Autoimmune diseases that would interfere with an immunologic response (e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis)
- Concurrent medical condition that would preclude compliance or immunologic response to study treatment
- Concurrent serious infection, including active tuberculosis, or other serious medical condition
- Pregnancy or lactation (serum human chorionic gonadotropin [HCG] test must be negative in fertile women at screening visit)
- Known gentamicin allergy
- Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus or trichophyton (based upon availability)
Contact: Francois Martelet, MD | 215-241-9760 | fmartelet@avax-tech.com |
United States, Florida | |
Baptist Cancer Institute | Not yet recruiting |
Jacksonville, Florida, United States, 32207 | |
Contact: Troy Guthrie, MD 904-202-7998 Troy.Guthrie@BMCJAX.com | |
Principal Investigator: Troy Guthrie, MD | |
United States, Illinois | |
University of Illinois at Chicago Cancer Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Cathleen Schaffer, RN 312-413-3863 CSchaffe@uic.edu | |
Contact: Michael Warso, MD warso@uic.edu | |
Principal Investigator: Michael A. Warso, MD | |
Cancer Treatment Centers of American - Midwestern | Recruiting |
Zion, Illinois, United States, 60099 | |
Contact: Joy Jardinico, RN 847-731-4143 joy-jardinico@ctca-hope.com | |
Contact: Stephen Ray, MD stephen.ray@ctca-hope.com | |
Principal Investigator: Stephen Ray, MD | |
United States, Kentucky | |
University of Louisville School of Medicine | Not yet recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Deborah Hulsewede, CCRC, CCRP 502-629-3308 deborah.hulsewede@nortonhealthcare.org | |
Principal Investigator: Kelly McMasters, MD | |
University of Kentucky - Markey Cancer Center | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Heather Dunn 859-257-4464 hldunn2@email.uky.edu | |
Principal Investigator: John J Rinehart, MD | |
United States, New Hampshire | |
Dartmouth-Hitchcock Cancer Center | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
Contact: Dorie Belloni 603-653-3567 Dorothy.R.Belloni@Dartmouth.EDU | |
Principal Investigator: Marc Ernstoff, MD | |
United States, Oklahoma | |
Cancer Treatment Centers of America - SouthWestern | Not yet recruiting |
Tulsa, Oklahoma, United States, 74133 | |
Contact: Michele M Sumner, BS 918-286-5450 Michele.Sumner@ctca-hope.com | |
Contact: Pierre J Greef, MD 918-286-5450 | |
Principal Investigator: Pierre J. Greef, MD | |
United States, Pennsylvania | |
Thomas Jefferson University | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Takami Sato, MD 215-955-1752 t_sato@mail.jci.tju.edu | |
Principal Investigator: Takami Sato, MD | |
St. Lukes Cancer Center | Recruiting |
Bethlehem, Pennsylvania, United States, 18015 | |
Contact: Kelly Filchner, MSN 610-954-3582 FilchnK@slhn.org | |
Principal Investigator: Sanjiv Agarwala, MD | |
University of Pennsylvania Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Mary Carberry 215-614-1813 mary.carberryi@uphs.upenn.edu | |
Principal Investigator: Lynn M Schuchter, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Peggy Tong, RN 713-745-5030 PLTong@MDAnderson.org | |
Principal Investigator: Jeffrey Lee, MD | |
Belgium | |
Universite Catholique de Louvain (UCL) | Recruiting |
Brussels, Belgium, 1200 | |
Contact: Aline Duquenne 32 2 764 5427 Aline.Duquenne@uclouvain.be | |
Principal Investigator: Jean-Francois Baurain, MD | |
Centre Hospitalier Regional de Namur | Recruiting |
Namur, Belgium, 5000 | |
Contact: Jean-Phillippe Hermanne, MD 32 81 72 60 30 Hermanne@ideone.BE | |
Principal Investigator: Jean-Phillippe Hermanne, MD |
Study Director: | Francois Martelet, MD | AVAX Technologies |
Labels: AVAX, Clinical Trial, M-Vax, melanoma, Survivors
2 comments:
This study is very beneficial for people with melanoma and in a program called tinea corporis
is said that the existing vaccine was not as effective as others that are creating is a breakthrough for medicine ... thanks for the article
Melanoma is a skin disease condition in which malignant tumor is formed that is originated from melanocytes and they bring melanin. Melanomas are black or brown in color and in some cases they stop producing pigments and so the color changes to pink, skin colored, and sometimes even red.
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