Anal Carcinoma, Biliary Tract Cancer, Bone Sarcomas, Breast Carcinoma, Carcinoma of Unknown Origin, Primary, Cervical Carcinoma, Colorectal, Endometrial Carcinoma, Esophageal Carcinoma, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Melanoma, Mesothelioma, Neuroendocrine Cancer, Ovarian, Pancreatic Carcinoma, Prostate, Renal, Small Cell Lung Carcinoma, Soft Tissue Sarcomas, Testicular Cancer, Thyroid Cancer
Conditions
Keywords
Cancer Vaccine
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALPSMA/PRAME
Low dose
Sponsors
Mannkind Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | Every 6 Weeks |
Countries
United States
Outcome results
None listed