Vaccine Therapy in Treating Patients With Metastatic Melanoma

Completed · Phase 1

Conditions studied: Melanoma (Skin)

In brief

RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.

Key facts

Study ID

NCT00003224

Run by

University of Virginia

People needed

22

Starts

1996-02-01

Last updated by the study team

2014-11-20

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above)
• Age: 18 to 79
• Performance status: ECOG 0-2
• Life expectancy: Greater than 12 months
• Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL
• Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN
• Renal: Creatinine no greater than 1.5 times ULN

You may not qualify if…

• patients currently receiving cytotoxic chemotherapy or who have received that therapy within the preceding 3 months
• known or suspected allergies to any component of the treatment vaccine
• unresectable tumor llikely to cause symptoms and for which therapy is anticipated within 3 months.
• receiving acute treatment for seriouis infection within 14 days.
• Patients with bulky disease, or with multiple brain metastases, but solitary brain metastases treated successfully with surgery or gamma knife may be eligible.
• Any of the following with 3 months:
• agentes with putative immunomodulating activity (except NSAIDs)
• allergy desensitizing injections
• other investigational agents
• interferons
• corticosteroids
• any growth factors
• prior melanoma vaccinations
• pregnancy or the possibility of becoming pregnant on study
• medical contraindication or potential problems in complying with the requirements of the protocol.

Where it is running

• Cancer Center, University of Virginia HSC — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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