Status:
TERMINATED
Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma
Lead Sponsor:
Ludwig Institute for Cancer Research
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purposes of this study are to describe the immune response to individual peptides after immunization with a combination of 8 peptides and CpG 7909 or Montanide ISA51; to determine the safety of th...
Detailed Description
Patients received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with either CpG 7909 or Montanide ISA51, at 2-week intervals. The 8 peptides were injected at 8 distinct in...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically proven cutaneous melanoma, or clear cell sarcoma, which is considered as a subtype of melanoma.
- Melanoma must be at one of the following AJCC 2002 stages:
- Regional metastatic disease (any T; N2b, N2c or N3; M0).
- Distant metastatic disease (any T; any N; M1a, M1b or M1c), except brain or leptomeningeal localizations, and except elevated LDH.
- Patients must be HLA-A2.
- A pre-immune tumor biopsy must be kept frozen for post-study PCR analysis.
- Presence of at least one measurable or non-measurable tumor lesion.
- Expected survival of at least 3 months.
- Karnofsky performance scale ≥70 or WHO performance status of 0 or 1.
- Within the last 4 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which must be within the ranges specified:
- Lab Parameter Range
- Hemoglobin ≥ 10 g/dl or ≥ 6,25 mmol/l
- Granulocytes ≥ 1,500/µl
- Lymphocytes ≥ 700/µl
- Platelets ≥ 100,000/µl
- Serum creatinine ≤ 2.0 mg/dl or ≤ 177 μmol/l
- Serum bilirubin ≤ 2.0 mg/dl or ≤ 34.2 μmol/l
- ASAT and ALAT ≤ 2 x the normal upper limits
- LDH ≤ the normal upper limit.
- Viral tests:
- HIV (human immunodeficiency virus): negative antibodies.
- HBV (hepatitis B virus): negative antigens; antibodies may be positive.
- HCV (hepatitis C virus): negative antibodies.
- Age ≥ 18 years.
- Able and willing to give valid written informed consent.
- Exclusion Criteria
- Previous treatment with more than one regimen of systemic chemotherapy, combined or not with non-specific immunotherapy such as interferon alpha or interleukins. Chemoimmunotherapy or radiotherapy must be stopped within the preceding 4 weeks (6 weeks for nitrosoureas and mitomycin C).
- Clinically significant heart disease (NYHA Class III or IV) i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias.
- Active immunodeficiency or autoimmune disease. Vitiligo was not an exclusion criterion.
- Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00145158
Start Date
January 1 2005
End Date
March 12 2009
Last Update
October 10 2022
Active Locations (2)
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1
Clinique Universitaires St-Luc
Brussels, Belgium, B-1200
2
Ludwig Institute for Cancer Research
Brussels, Belgium, B-1200