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Phase 1 N=22 Randomized Treatment

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Melanoma (Skin)

Bottom Line

View on ClinicalTrials.gov: NCT00003224 ↗
Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Nov 2014
Primary outcome: Primary: Safety: Grade 3 Adverse Events — 1; 0 participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
QS21 (Biological); IFA (incomplete Freund's adjuvant) (Biological); p946 (Biological); p946/tet-p (Biological); Tet-p (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Virginia
Primary completion
Aug 2000

Outcome Measures

OutcomeResultp-value
PRIMARY
Safety: Grade 3 Adverse Events		 1; 0 —
SECONDARY
Immunogenicity of Each Vaccine Regimen		 1; 1; 0; 1; 0; 0 —

Summary

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.

Eligibility Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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