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The present clinical trial is a dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on a large number of solid cancers.
The majority of tumors are ignored by the immune system and it was thought for a long time that tumor antigens did not exist. However, recently a number of tumor antigens have been described. These antigens reside on cancer cells and can be recognized by specific T-cells which can ultimately attack and destroy the tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Cohort | Experimental |
| |
| High Dose Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA/PRAME | Biological | Low dose |
| |
| PSMA/PRAME |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the immunologic response to the treatment with MKC1106-PP regimen and 2) to determine the safety and adverse event profile of MKC1106-PP | Every 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| to determine the blood plasmid levels by PCR analysis | Every 6 Weeks | |
| measure cytokine levels | Every 6 Weeks | |
| to describe any objective tumor responses to the treatment with MKC1106-PP |
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Inclusion Criteria:
18 years of age or older Advanced, refractory solid malignancy that is histologically proven Measurable disease ECOG performance status of 0, 1 or 2 Adequate bone marrow reserve as evidenced by a Absolute neutrophil count (ANC) = 1,500/microL; Platelet count = 100,000/microL Adequate renal and hepatic function as evidenced by a serum creatinine = 1.5 mg/dL; Serum total bilirubin = 2.0 mg/dL; Alkaline phosphatase = 3X the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases); SGOT/SGPT = 3X the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases)
Exclusion Criteria:
Symptomatic central nervous system (CNS) metastases Any autoimmune disorder Positive HIV, hepatitis B or hepatitis C antibody test Any allogeneic transplant Congestive heart failure Affected inguinal lymph nodes (metastatic process) or lack inguinal lymph nodes (resection)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tuscon | Arizona | 85724-5024 | United States | ||
| Lombardi Comprehensive Cancer Center at Georgetown |
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| Biological |
high dose |
|
| Every 6 Weeks |
| Washington D.C. |
| District of Columbia |
| 20057 |
| United States |
| H Lee Moffitt Cancer Center University of So Florida | Tampa | Florida | 33612 | United States |
| Nevada Cancer Institute | Sparks | Nevada | 89431 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D013736 | Testicular Neoplasms |
| D013964 | Thyroid Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D008654 | Mesothelioma |
| D001943 | Breast Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D018278 | Carcinoma, Neuroendocrine |
| D008113 | Liver Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D001005 | Anus Neoplasms |
| D001859 | Bone Neoplasms |
| D012509 | Sarcoma |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D006258 | Head and Neck Neoplasms |
| D013959 | Thyroid Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018301 | Neoplasms, Mesothelial |
| D001941 | Breast Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010182 | Pancreatic Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D008107 | Liver Diseases |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
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