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

NCT01026051 | Terminated Phase 2

• 1 other identifier: MKC1106-MT-002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Stage III Melanoma; Stage IV Melanoma

Keywords

Cancer Vaccine, Immunotherapy, Melanoma

Outcome Measures

Primary Outcomes (1)

• 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)

  12 Months

Secondary Outcomes (3)

• 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

  12 Months

• To identify and characterize correlations between biological activity (immune response), target antigen expression and clinical efficacy.

  12 months

• To further assess the safety profile and tolerability

  12 months

Interventions

MKC1106-MT BIOLOGICAL

Cancer Vaccine, Immunotherapy, Melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (4)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

UCLA Medical Center

Los Angeles, California, 90034, United States

Location

Martin Memorial

Stuart, Florida, 34994, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chief Scientific Officer

  Mannkind Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2012
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

US (4)