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Search / Trial NCT01435499

Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Sep 14, 2011

Trial Information

Current as of July 24, 2025

Completed

Keywords

Immunotherapy Vaccine Gvax Gm Csf

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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).

About Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is a leading research and treatment facility dedicated to advancing the understanding and treatment of cancer. Renowned for its multidisciplinary approach, the center integrates cutting-edge research with patient care, fostering innovation in cancer therapies and prevention strategies. With a commitment to translational medicine, the center conducts clinical trials that aim to bring laboratory discoveries directly to patients, enhancing therapeutic options and improving outcomes. As a National Cancer Institute-designated comprehensive cancer center, it emphasizes collaboration among researchers, clinicians, and patients to tackle the complexities of cancer and develop personalized treatment plans.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Evan J Lipson, M.D.

Principal Investigator

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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