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Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma


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

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Trial Information

Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma


Inclusion Criteria:



- Diagnosis of melanoma, AJCC stage IIB, IIC, III, or IV (MIa), with histologic
confirmation by the Department of Pathology at MSKCC.

- Patients must be HLA-A*0201 positive, based on high resolution DNA level typing.

- Expected survival of greater than 3 months.

- Karnofsky performance status of 70 or higher

- All patients should have undergone surgical treatment appropriate to their stage of
disease

- Patients may not have received chemotherapy, immunotherapy, or radiation within a
minimum of 28 days (minimum of 42 days for nitrosoureas or mitomycin) before
participation in this protocol.

Exclusion Criteria:

- Pregnant or lactating women because of unknown risks to the fetus or infant.

- Patients requiring systemic corticosteroids or comparable exogenous immunosuppressive
agent(s) (no exclusion for use of NSAIDs).

- Patients with a known immunodeficiency (e.g., infection with HTLV-1,2, HIV-1,2;
etc.).

- Patients with coexisting autoimmune diseases, except vitiligo.

- Patients with baseline impairments of hematologic, hepatic, or renal function (CTCAE
v4.0 > grade 1, ANC < 1500, hgb < 10.0 g/dl, plts < 75,000/ul, AST > 3x ULN,
creatinine > 1.5xULN), all assessed within four weeks of study entry.

- Patients with organ allografts.

- Patients who are status post splenectomy or status post splenic irradiation.

- Patients with a history of documented pre-existing retinal/choroidal disease.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

safety

Outcome Description:

Toxicity will be graded according to standard NCI/CTEP toxicity criteria. This protocol will use the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

James Young, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-229

NCT ID:

NCT01456104

Start Date:

October 2011

Completion Date:

October 2014

Related Keywords:

  • Melanoma
  • vaccine
  • stage IIB
  • stage IIC
  • stage III
  • stage IV (MIa)
  • Langerhans-type dendritic cells
  • Immune Responses
  • 10-229
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021