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A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma


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

Thank you

Trial Information

A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma


Inclusion Criteria:



- Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with
clinicopathologic stage IIB, IIC, III or IV that has been completely resected

- Patients must be able to provide informed consent.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Life expectancy of at least 6 months.

- Adequate hematologic function.

- Adequate renal function

- Adequate hepatic function

- Patients of both genders must agree to practice effective birth control during the
study period and for at least 4 weeks after the last treatment.

Exclusion Criteria:

- Patients whose primary site of melanoma is ocular.

- Are undergoing or have undergone in the past 4 weeks any systemic treatment for
melanoma.

- Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation
therapy.

- Have active systemic infections, coagulation disorders (including therapeutic
anticoagulation), or other major medical or psychiatric illnesses.

- Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or
anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects
of these conditions).

- Documented history of autoimmune disease, for example, systemic lupus erythematosus,
sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.

- Any form of primary or secondary immunodeficiency. This would include hereditary
disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired
immune deficiencies such as following bone marrow transplantation.

- Requirement for systemic steroid therapy or immunosuppressive therapy.

- Have received any type of cancer immunotherapy, including but not limited to
interleukin-2, interferon alfa or melanoma vaccines.

- Have been diagnosed with another invasive cancer within the past 3 years.

- Radiographic evidence of melanoma recurrence.

- Pregnant or lactating women.

- Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn,
Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Administering Melanoma GVAX With and Without Cyclophosphamide

Outcome Description:

To determine the side effects and tolerability of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide, for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma.

Outcome Time Frame:

2.5 years

Safety Issue:

Yes

Principal Investigator

Evan J Lipson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Authority:

United States: Food and Drug Administration

Study ID:

J1112

NCT ID:

NCT01435499

Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Melanoma
  • immunotherapy
  • vaccine
  • GVAX
  • GM-CSF
  • Melanoma

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231