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Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688090
First Posted: June 2, 2008
Last Update Posted: August 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mannkind Corporation
  Purpose
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 melanomas.

Condition Intervention Phase
Advanced Melanoma Stage III and IV Melanoma Biological: Biological: MKC1106-MT Biological: Biological: MKCC1106-MT Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open Label, Non-Randomized Dose Escalation Study to Evaluate the Safety, Tolerability, Immune Response and Clinical Response of Multiple Doses of MKC1106-MT in Subjects With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Is to assess the safety and tolerability of MKC1106-MT regimen [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • To assess the immune response (by tetramer and ELISPOT analysis) of MKC1106-MT when administered to subjects with advanced melanoma [ Time Frame: 6 Weeks ]
  • To determine pMEL-TYR plasmid level in the blood by PCR analysis [ Time Frame: 6 Weeks ]
  • To determine target antigen expression (Melan A and tyrosinase) and beta2 microglobulin expression in the tumor tissue [ Time Frame: 6 Weeks ]
  • To document any preliminary evidence of clinical response [ Time Frame: 6 Weeks ]

Enrollment: 19
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-Dose Peptide Cohort Biological: Biological: MKCC1106-MT
Cancer Vaccine, Immunotherapy
Experimental: High-Dose Peptide Cohort Biological: Biological: MKC1106-MT
Cancer Vaccine, Immunotherapy

Detailed Description:
The multi-component active immunotherapy, MKC1106-MT, consists of 1 plasmid dose and 2 peptides doses designed to stimulate an immune reaction to two tumor associated antigens (Melan-A and tyrosinase). The plasmid component will be administered on Days 1,4, 15 and 18 of each treatment cycle followed by administration of peptides on Days 29 and 32 of the treatment cycle. All components will be administered separately into superficial inguinal lymph nodes under ultrasound guidance.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer [AJCC 6th edition] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.

Patients enrolled in the Phase 2 portion of the trial must have measurable disease by the RECIST criteria ECOG performance status of 0 or 1 Life expectancy = 3 months 18 years of age or older at screening evaluation Positive for HLA-A2, and more precisely, express A*0201 as assessed by DNA typing Tumor material from prior biopsy / surgical resection available for analysis of expression of melanoma specific antigens Adequate bone marrow reserve as evidenced by: Absolute neutrophil count (ANC) = 1,000/?L & Platelet count = 75,000/?L Adequate renal function as evidenced by: serum creatinine = 1.5 mg/dL Adequate hepatic function as evidenced by: Serum total bilirubin = 2.0 mg/dL & SGOT/SGPT = 3 times the ULN for the reference lab (= 5 the ULN for the reference lab for subjects with known hepatic metastases) Subjects must have recovered to at least baseline or Grade 1 toxicity from the effects of any prior surgery, radiotherapy or other therapies including but not limited to chemotherapy Women of childbearing potential as well as fertile men and their partners must agree to use an effective method of contraception or to abstain from sexual intercourse during the clinical trial and for 90 days following the last dose of the investigational new drug Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed

Exclusion Criteria:

No systemic infection requiring treatment Symptomatic brain metastases and/or progression of CNS metastases within the past 4 weeks; patients with treated CNS metastases (by surgery and/or radiation), who are neurologically stable, and who are no longer taking glucocorticoids, are eligible Subjects with autoimmune disorders, including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, Sjogren's syndrome, mixed connective tissue disease, ankylosing spondylitis, Hashimoto's thyroiditis, bullous pemphigus, sarcoidosis, Behçet's syndrome, vasculitis, familial Mediterranean fever, Wegener's granulomatosis or Goodpasture's syndrome Positive HIV, hepatitis B or hepatitis C antibody test Subjects who underwent allogeneic transplant New York Heart Association Grade III or IV congestive heart failure Medical, sociological or psychological conditions that may compromise compliance or participation in the clinical trial or interfere with the interpretation of the results Subjects who have taken drugs that negatively affect immune function such as systemic corticosteroids or other immunomodulatory drugs including, but not limited to, interferon-alpha, interferon-beta, interleukin-2, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept or efalizumab, within one month preceding the screening Subjects who are lactating, pregnant, or planning to become pregnant within three months of treatment completion Subjects who have received any investigational drug within the preceding four weeks of enrollment Subjects who have affected inguinal lymph nodes (metastatic process) or lack of inguinal lymph nodes (resection)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688090


Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90034
United States, Florida
H Lee Moffitt Cancer Center University of So Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Mannkind Corporation
  More Information

Responsible Party: Mihail Obrocea/Vice President-Oncology Medical & Regulatory Affairs, MannKind
ClinicalTrials.gov Identifier: NCT00688090     History of Changes
Other Study ID Numbers: MKC1106-MT-001
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: August 3, 2010
Last Verified: August 2010

Keywords provided by Mannkind Corporation:
Immunotherapy, Melanoma, Cancer Vaccine

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs