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

Sponsor

Mannkind Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT01026051

Collaborator

(none)

Enrollment

Locations

Duration (Months)

1.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stage III Melanoma Stage IV Melanoma	Biological: MKC1106-MT	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Jul 1, 2012

Outcome Measures

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) [12 Months]

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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Angeles Clinic and Research Institute	Los Angeles	California	United States	90025
2	UCLA Medical Center	Los Angeles	California	United States	90034
3	Martin Memorial	Stuart	Florida	United States	34994
4	Nevada Cancer Institute	Las Vegas	Nevada	United States	89135

Sponsors and Collaborators

Mannkind Corporation

Investigators

Study Chair: Chief Scientific Officer, Mannkind Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mannkind Corporation

ClinicalTrials.gov Identifier:

NCT01026051

Other Study ID Numbers:

MKC1106-MT-002

First Posted:

Dec 4, 2009

Last Update Posted:

May 15, 2012

Last Verified:

May 1, 2012

Keywords provided by Mannkind Corporation

Cancer Vaccine, Immunotherapy, Melanoma

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of May 15, 2012