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

This study has been terminated.
(Financial/Business Reasons)
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01026051
First received: December 3, 2009
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

The clinical trial is evaluating a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanoma


Condition Intervention Phase
Stage III Melanoma
Stage IV Melanoma
Biological: MKC1106-MT
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open Label, Non-Randomized 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:
  • To evaluate the objective response, where response is defined as either complete response (CR), partial response (PR), or stable disease (SD) for 12 weeks or longer (CR, PR, and SD are defined according to RECIST 1.1 criteria) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess clinical efficacy of MKC1106-MT in subjects with advanced melanoma measured at 6 months and 1 year by (1) time to progression, progression-free survival [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • To identify and characterize correlations between biological activity (immune response), target antigen expression and clinical efficacy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To further assess the safety profile and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: MKC1106-MT
    Cancer Vaccine, Immunotherapy, Melanoma
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 non-diseased superficial inguinal lymph nodes under ultrasound guidance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of regional or distant metastatic melanoma (stage IIIB, IIIC, or IV) confined to skin, subcutaneous tissue, or lymph nodes that is refractory to standard of care, or for which no curative standard therapy exists (Note: Subjects who are therapy-naïve will also be eligible.)
  • Measurable disease by the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
  • ECOG performance status of 0 or 1
  • Life expectancy > or = 3 months
  • 18 years of age or older at screening evaluation
  • Subjects must be able to provide informed consent for participation in the clinical trial before any protocol-specific clinical trial procedure is performed
  • Positive for HLA-A2 and, more precisely, for expression of A*0201 as assessed by DNA typing
  • Tumor material from prior biopsy/surgical resection available for analysis of expression of melanoma specific antigens
  • Adequate coagulation function as evidenced by prothrombin time (PT) and partial thromboplastin time (PTT) values within the normal range
  • Adequate bone marrow reserve as evidenced by Absolute neutrophil count (ANC) > or = 1,000/mL; platelet count > or = 75,000/mL
  • 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 drug.
  • Subjects who have received local radiation therapy (less than one-fourth of bone marrow) are eligible.

Exclusion Criteria:

  • Subjects with visceral metastasis (Note: Subjects with stable CNS metastasis or fully treated CNS metastatic disease [eg, radiation therapy] are eligible.)
  • Active infection requiring treatment
  • Systemic inflammatory disease requiring chronic maintenance or suppressive therapy
  • Positive antibody test result for HIV, hepatitis B, or hepatitis C
  • History of allogeneic transplant
  • Medical, sociological, or psychological conditions that may compromise compliance or participation or that may interfere with the interpretation of the results
  • History of receiving immunosuppressive drugs within 1 month before dosing
  • Subjects who are lactating, pregnant, or planning to become pregnant within 3 months of completing treatment
  • Subjects who received an investigational drug within the 4 weeks before dosing
  • Prior systemic radiation therapy (more than one-fourth of bone marrow)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026051

Locations
United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
UCLA Medical Center
Los Angeles, California, United States, 90034
United States, Florida
Martin Memorial
Stuart, Florida, United States, 34994
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Chair: Chief Scientific Officer Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01026051     History of Changes
Other Study ID Numbers: MKC1106-MT-002
Study First Received: December 3, 2009
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014