Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Advanced Melanoma
A Multipeptide Vaccine in Melanoma Patients With Evaluation of the Injection Site Microenvironment
NCT00705640CI-TRIAL-00025206Mel48completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vaccine therapy may help the body build an effective immune response to kill tumor cells. PURPOSE: This randomized clinical trial is studying how well vaccine therapy works in treating patients with advanced melanoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Malignant Conjunctival Neoplasm | Malignant Conjunctival Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| multi-epitope melanoma peptide vaccine | Biological | — | UNRESOLVED |
| tetanus toxoid helper peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Arm 1A
- description
- Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive no replicate vaccine. Patients undergo surgical biopsy at replicate vaccine site on day 1.
- interventionNames
- Biological: incomplete Freund's adjuvant
- Biological: multi-epitope melanoma peptide vaccine
- Biological: tetanus toxoid helper peptide
- Procedure: biopsy
- type
- EXPERIMENTAL
- label
- Arm 1B
- description
- Patients receive primary vaccine, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Patients receive replicate vaccine comprising incomplete Freund's adjuvant only SC and ID on day 1 and undergo surgical biopsy at replicate vaccine site on day 8 (1 week after replicate vaccine 1).
- interventionNames
- Biological: incomplete Freund's adjuvant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed melanoma that meets one of the following criteria:
* Stage IIB-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within the past 6 months
* Stage III or IV melanoma with disease
* Persistent or metastatic disease allowed if RECIST criteria for measurable disease is not met
* Multiple primary melanomas allowed
* Prior or concurrent metastasis from a cutaneous, mucosal, ocular, or unknown primary site allowed
* No clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation (e.g., untreated bone metastases at risk for fracture or rapidly progressive low-volume disease)
* Brain metastases allowed if all of the following criteria are met:
* The total number of brain metastases ever is ≤ 3
* The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy
* There has been no evident growth of any brain metastasis since treatment
* No treated brain metastasis \> 2 cm in diameter
* At least two intact axillary and/or inguinal lymph node basins
* Prior lymph node biopsy allowed if lymphoscintigraphy demonstrates intact drainage to a node in that basin
* If a sentinal lymph node is not located by lymphoscintigraphy, patient is not eligible for study
* HLA-A1, -A2, -A3, or -A11 positive
* Either eligible for, but refused interferon therapy OR not a candidate for interferon therapy for the following reasons:
* Active ischemic heart disease or cerebrovascular disease
* Anginal syndrome requiring ongoing medications or history of myocardial infarction or arrhythmia disorder
* History of treatment for depression, active depression, or other psychiatric disorder
* Autoimmune disorders
* Hypersensitivity to interferon-alfa or any component associated with interferon therapy
* Debilitating medical conditions such as severe pulmonary disease or severe diabetes mellitus
* Thyroid abnormalities, where thyroid function cannot be maintained in the normal range without medication
* Resected stage IV melanoma
* Discontinued interferon therapy due to the occurrence of a major toxicity that has been documented by the treating physician
* Experienced tumor progression while on interferon or after completing interferon therapy
* Missed the standard-of-care enrollment window for interferon therapy initiation
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* ANC \> 1,000/mm\^3
* Platelets \> 100,000/mm\^3
* Hemoglobin \> 9 g/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Hepatitis C and HIV negative (antibody screening)
* Hemoglobin\_A1C level \< 7%
* Body weight ≥ 110 pounds
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during study treatment
* No New York Heart Association class III-IV heart disease
* No known or suspected allergies to any component of the vaccine
* No medical contraindication or potential problem in complying with the requirements of the protocol
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior peptide vaccines (including MELITAC 12.1 and similar vaccines) or non-peptide vaccines allowed
* At least 1 week since prior stereotactic radiotherapy, such as gamma knife
* No influenza vaccine ≥ 2 weeks before, during, and ≥ 2 weeks after completion of study therapy
* More than 4 weeks since prior and no concurrent use of any of the following:
* Systemic cytotoxic chemotherapy (6 weeks for nitrosoureas)
* Radiotherapy
* Other experimental therapy
* Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids)
* Allergy desensitization injections
* Systemic corticosteroids, administered parenterally or orally
* Inhaled steroids (e.g., fluticasone propionate \[Advair® or Flovent®\] or triamcinolone acetonide \[Azmacort®\])
* Topical corticosteroids and steroids with very low solubility administered nasally for local effects only allowed (e.g., mometasone furoate \[Nasonex®\])
* Growth factors (e.g., sargramostim \[GM-CSF\], filgrastim \[G-CSF\], or epoetin alfa)
* Interferon therapy
* Aldesleukin or other interleukins
* Street drugs
* At least 1 month since prior and no other concurrent investigational drugs or therapy
* At least 12 weeks since prior melanoma vaccine for patients who have recurred or progressed either after or during treatment with vaccineReferences
Publications (3)
- DERIVEDPollack KE, Meneveau MO, Melssen MM, Lynch KT, Koeppel AF, Young SJ, Turner S, Kumar P, Sol-Church K, Mauldin IS, Slingluff CL Jr. Incomplete Freund's adjuvant reduces arginase and enhances Th1 dominance, TLR signaling and CD40 ligand expression in the vaccine site microenvironment. J Immunother Cancer. 2020 Apr;8(1):e000544. doi: 10.1136/jitc-2020-000544. PMID 32350119
- DERIVEDJudge JM, Chianese-Bullock KA, Schroen AT, Slingluff CL Jr. Usefulness of prestudy assessment of patient willingness to undergo tissue biopsy for correlative studies in a melanoma vaccine trial. Clin Trials. 2013 Feb;10(1):143-50. doi: 10.1177/1740774512464438. Epub 2012 Nov 29. PMID 23197414
- DERIVEDSchaefer JT, Patterson JW, Deacon DH, Smolkin ME, Petroni GR, Jackson EM, Slingluff CL Jr. Dynamic changes in cellular infiltrates with repeated cutaneous vaccination: a histologic and immunophenotypic analysis. J Transl Med. 2010 Aug 20;8:79. doi: 10.1186/1479-5876-8-79. PMID 20727190