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The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.
Patients with stage III or IV melanoma need to have at least one tumor mass of at least 2.5 cm (about 1 inch) diameter than can be removed for vaccine production. If the vaccine is successfully made and if the patient is eligible, the patient will be assigned to receive one of 4 doses of the vaccine, include one group that will receive a zero dose. All patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and BCG. Eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period. Before and after vaccine administration, patients will be tested for immunity to their own melanoma cells by DTH testing, which is similar to a tuberculosis test. All side effects caused by the vaccine will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 'Autologous, DNP-modified vaccine (M-Vax)' |
|
| B | Experimental | Autologous, DNP-Modified Vaccine (MVax) |
|
| C | Experimental | Autologous, DNP-Modified Vaccine (MVax) |
|
| D | Placebo Comparator | 0 cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous, DNP-modified vaccine (M-Vax) | Biological | 5.0, 2.5, 0.5, or 0 cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune response to patients' own melanoma cells | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Berd, MD | AVAX Technologies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | United States | |||
| Pacific Oncology and Hematology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14691123 | Background | Berd D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol. 2004 Feb 1;22(3):403-15. doi: 10.1200/JCO.2004.06.043. Epub 2003 Dec 22. |
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| Autologous, DNP-Modified Melanoma Vaccine | Biological | 5 million cells |
|
|
| Autologous, DNP-Modified Vaccine | Biological | 2.5 million cells |
|
|
| Autologous, DNP-Modified Vaccine | Biological | 0.5 million cells |
|
|
| Autologous, DNP-Modified Vaccine | Biological | 0 cells |
|
|
| San Diego |
| California |
| 92024 |
| United States |
| University of Illinois School of Medicine | Chicago | Illinois | 60612 | United States |
| University of Louisville | Louisville | Kentucky | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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