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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Melanoma, Stage III and IV Melanoma

Thank you

Trial Information

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


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.


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, Beh├žet'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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Is to assess the safety and tolerability of MKC1106-MT regimen

Outcome Time Frame:

6 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MKC1106-MT-001

NCT ID:

NCT00688090

Start Date:

June 2008

Completion Date:

May 2010

Related Keywords:

  • Advanced Melanoma
  • Stage III and IV Melanoma
  • Immunotherapy, Melanoma, Cancer Vaccine
  • Melanoma

Name

Location

UCLA Medical Center Los Angeles, California  90095-7059
H Lee Moffitt Cancer Center University of So Florida Tampa, Florida  33612