Trials / Completed
CompletedNCT00423254
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
A Phase I Multicenter, Open Label, Clinical Trial of Immune Response, Safety and Tolerability of DNA Vector pPRA-PSM With Synthetic Peptides E-PRA and E-PSM in Subjects With Advance Solid Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Mannkind Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ovarian
- Melanoma
- Renal
- Prostate
- Colorectal
- Endometrial Carcinoma
- Cervical Carcinoma
- Testicular Cancer
- Thyroid Cancer
- Small Cell Lung Carcinoma
- Mesothelioma
- Breast Carcinoma
- Esophageal Carcinoma
- Gastric Cancer
- Pancreatic Carcinoma
- Neuroendocrine Cancer
- Liver Cancer
- Gallbladder Cancer
- Biliary Tract Cancer
- Anal Carcinoma
- Bone Sarcomas
- Soft Tissue Sarcomas
- Carcinoma of Unknown Origin, Primary
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PSMA/PRAME | Low dose |
| BIOLOGICAL | PSMA/PRAME | high dose |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2009-09-01
- Completion
- 2009-11-01
- First posted
- 2007-01-18
- Last updated
- 2010-08-03
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00423254. Inclusion in this directory is not an endorsement.