Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00423254

Run by

Mannkind Corporation

People needed

12

Starts

2007-02-01

Expected to finish

2009-11-01

Last updated by the study team

2010-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Arizona Cancer Center — Tuscon, Arizona, United States
• Lombardi Comprehensive Cancer Center at Georgetown — Washington D.C., District of Columbia, United States
• H Lee Moffitt Cancer Center University of So Florida — Tampa, Florida, United States
• Nevada Cancer Institute — Sparks, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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