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A Phase I Trial Testing Multiple Antigen-Engineered DC Followed by IFNa2b Boost for Immunization of HLA-Unrestricted Melanoma Patients


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

A Phase I Trial Testing Multiple Antigen-Engineered DC Followed by IFNa2b Boost for Immunization of HLA-Unrestricted Melanoma Patients


This is a Phase I, single site study to evaluate the immunological effects of autologous DC
transduced with the MART-1, tyrosinase and MAGE-A6 (melanoma associated antigens, MAA) genes
in 30 subjects with recurrent, unresectable stage III, IV metastatic melanoma (M1a, M1b,
M1c). AdVTMM2-transduced DC, 10e7, will be given intradermally (i.d.) every two weeks for a
total of 3 vaccines.

After the DC vaccines, subjects will be randomized to either receive a boost of high dose
IFNa2b or no boost.

Subjects randomized to receive the IFNa2b boost will receive Interferon-a2b, 20 MU/m2/d
(rounded to the nearest 1 million units) administered intravenously for 5 consecutive days
(Monday through Friday) every week for 4 weeks (induction). Administration will begin 30
days after the 3rd vaccine.

The end-points of this study are local and systemic toxicity, immunological response,
generation of determinant spreading and anti-tumor immunity, and clinical response.


Inclusion Criteria:



- Ability and willing to give consent

- Patients age 18 and older with recurrent, inoperable stage III, IV, M1a, b or c
melanoma (any tumor thickness and any number of lymph node involvement, and
in-transit metastases, or distant metastases) (AJCC).

Previously treated with any form of therapy (including chemotherapy, radiation therapy,
immunotherapy or surgery) for either metastatic, relapsed, or primary melanoma are
eligible for this trial, provided the previous treatment was completed > 30 days prior to
enrollment.

- Patients should have at least 2 subcutaneous, intracutaneous, and accessible tumor
deposits, lymph node or other site available for biopsy purposes.

- Both men and women may be enrolled. Premenopausal females must have a negative
pregnancy test prior to treatment and lactating females will have to discontinue
breast feeding to be eligible.

- ECOG Performance Status of 0 or 1.

- No previous evidence of class 3 or greater New York Heart Association cardiac
insufficiency or coronary artery disease.

- No previous evidence of opportunistic infection.

- Adequate baseline hematological and organ function as assessed by the following
laboratory values within 28 days prior to study entry:

Hemoglobin >/=9 g/dL Granulocytes >/=2,500/mm3 Lymphocytes >/=1000/mm3 Platelets
>100,000/mm3 Serum Creatinine the ULN Serum Bilirubin and organ function lab values along with the ECOG PS must be met prior to starting IFN╬▒
treatment.

- Subjects must have normal coagulation parameters as measured by PT/PTT.

Exclusion Criteria:

- Females of child-bearing potential (pre-menopausal) must have a negative serum
beta-HCG pregnancy test at screening.

- Subjects with acute infection: any acute viral, bacterial, or fungal infection which
requires specific therapy. Acute therapy must have been completed more than 14 days
prior to study treatment.

- Hep B & C and HIV-infected patients, due to concerns in the ability to stimulate an
effective immune response (determined by historical medical data).

- Subjects with acute medical problems such as ischemic heart or lung disease that may
be considered an unacceptable anesthetic or operative risk.

- Subjects with any underlying conditions which would contraindicate therapy with study
treatment (or allergies to reagents).

- Subjects with organ allografts.

- Subjects must be free of known brain metastases by contrast-enhanced CT/MRI scans or
have successfully-treated brain metastases and be asymptomatic for more than 1 month.

- Previous clinical evidence of an autoimmune disease.

- Concomitant Medication and Treatment: All allowed medications or treatments should be
kept to a minimum and recorded. All questions regarding concomitant medications
should be referred to the Investigator.

- Long term concurrent medications and/or treatments Not Allowed: Corticosteroids,
chemotherapy, cyclosporin A. Short term (approximately 1 week) use of topical,
low-dose or inhaled steroids may be allowed at the discretion of the investigator.
Injectables not allowed.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety

Outcome Description:

Types of adverse events associated with this Multiple Antigen-Engineered DC vaccine at the injection site and systemically.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

John M Kirkwood, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

09-021

NCT ID:

NCT01622933

Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Melanoma
  • melanoma
  • Melanoma

Name

Location

University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213