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

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.

Tracking Information
First Received DateJanuary 12, 2007
Last Changed DateAugust 2, 2010
Start DateFebruary 2007
Actual Primary Completion DateSeptember 2009
Primary Outcome Measures

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 [Time Frame: Every 6 Weeks]

Secondary Outcome Measures

to determine the blood plasmid levels by PCR analysis [Time Frame: Every 6 Weeks]

measure cytokine levels [Time Frame: Every 6 Weeks]

to describe any objective tumor responses to the treatment with MKC1106-PP [Time Frame: Every 6 Weeks]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • 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
Intervention
  • Biological: PSMA/PRAME
  • Biological: PSMA/PRAME
Study Arms / Comparison Groups2 / 0
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment12
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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)

Administrative Information
NCTIDNCT00423254
Responsible PartyMihail Obrocea/Vice President-Oncology - Medical & Regulatory Affairs, MannKind Corporation
SponsorMannkind Corporation
Verification DateAugust 2010
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