Status:
COMPLETED
Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Lead Sponsor:
Ahmad Tarhini
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Malignant Conjunctival Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete Freund's adjuvant...
Detailed Description
OBJECTIVES: * Determine the safety of a peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in inc...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma meeting the following criteria:
- Unresectable recurrent disease
- Stage III or IV disease
- Cutaneous, ocular, or mucosal melanoma
- Measurable disease as defined by the RECIST criteria
- HLA-A2 positive
- Prior brain metastases allowed provided adequate surgical or radiologic treatment for brain disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- WBC ≥ 3,000/mm³
- Lymphocytes ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN
- Lactic dehydrogenase ≤ 2.0 times ULN
- aPTT \< 40 seconds
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after completion of study therapy
- No conditions of immunosuppression
- Negative titers for antinuclear antibody (≤ 1/80) and antidouble stranded DNA (≤ 1/10)
- No serious illnesses including, but not limited to, any of the following:
- Bleeding disorders
- Autoimmune diseases
- Severe obstructive or restrictive pulmonary diseases
- Active systemic infections
- Inflammatory bowel disorders
- No serious cardiovascular disease including, but not limited to, any of the following:
- Uncontrolled congestive heart failure
- Hypertension
- Cardiac ischemia
- Myocardial infarction,
- Severe cardiac arrhythmia
- HIV1 and 2 negative
- HTLV-1 negative
- Hepatitis B and C negative
- No significant psychiatric disease, medical intervention, or other condition that, in the opinion of the principal investigator, would limit study compliance
- No active infection within the past week, including unexplained fever (temperature \> 38.1°C)
- PRIOR CONCURRENT THERAPY:
- Fully recovered from prior major surgery
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas), hormonal therapy, radiotherapy, or biological therapy
- More than 1 week since prior antibiotics
- More than 28 days since prior investigational agent
- No prior vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides alone or in combination
- Patients with history of vaccination with peptides other than MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides allowed
- More than 4 weeks since prior and no concurrent systemic immunosuppressive therapy, including steroids
- Patients on maintenance steroids given at physiologic doses because of adrenal insufficiency are eligible
- More than 2 weeks since prior and no concurrent treatment with systemic steroids, including oral steroids, continuous use of topical steroid creams or ointments, or any inhaled steroids
- No concurrent anticoagulants, except to keep an indwelling line patent
- No other concurrent anticancer therapy, including chemotherapy, immunotherapy, radiotherapy, experimental programs, and/or surgery
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00471471
Start Date
October 1 2008
End Date
December 1 2011
Last Update
June 22 2017
Active Locations (1)
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1
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232