Clinical trial · Interventional
Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
A Randomized Phase II Trial of Multi-Epitope Vaccination With Melanoma Peptides For Cytotoxic T Cells And Helper T Cells For Patients With Metastatic Melanoma
NCT00071981CI-TRIAL-00067619completedPhase 2Results postedClinicalTrials.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: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| melanoma helper peptide vaccine | Biological | — | UNRESOLVED |
| multi-epitope melanoma peptide vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| tetanus peptide melanoma vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I (12MP)
- description
- Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
- interventionNames
- Biological: incomplete Freund's adjuvant
- Biological: multi-epitope melanoma peptide vaccine
- Biological: sargramostim
- type
- EXPERIMENTAL
- label
- Arm II (12MP/Tet)
- description
- Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
- interventionNames
- Biological: incomplete Freund's adjuvant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed stage IV melanoma
* Multiple primary melanomas allowed
* Metastasis may be from a cutaneous, mucosal, ocular, or unknown primary site
* Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST criteria)
* Must have 2 extremities uninvolved with tumor
* Must have at least 2 intact (undissected) axillary and/or inguinal lymph node basins
* Prior sentinel node biopsy may not have violated the integrity of a nodal basin
* This extremity may still be considered for vaccination
* Human Lymphocyte Antigen (HLA)-A1, -A2, or -A3 positive
* Prior brain metastases allowed provided all of the following are true:
* Surgically resected or treated with gamma-knife or stereotactic radiosurgery
* No disease progression in the brain for the past 3 months
* More than 30 days since prior steroids for the management of brain metastases
* Age: 18 and over
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Adequate organ function measured within 4 weeks before randomization:
* White blood cell (WBC) at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Lymphocyte count at least 700/mm\^3
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) no greater than 2 times upper limit of normal (ULN)
* Bilirubin no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
* Lactic dehydrogenase no greater than 2 times ULN
* Creatinine no greater than 1.8 mg/dL
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except nonmetastatic squamous cell or basal cell skin cancer, ductal or lobular carcinoma in situ of the breast, or carcinoma in situ of the cervix
* At least 4 weeks since prior sargramostim (GM-CSF), interferon alfa-2b, or interleukin-2
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* More than 30 days since prior systemic corticosteroids, including any of the following:
* Therapeutic doses of oral steroids (e.g., prednisone or dexamethasone)
* Steroid inhalers (e.g., Advair)
* Topical steroids and nasal steroids with low systemic absorption (e.g., fluticasone) or steroids with low systemic absorption (e.g., triamcinolone hexacetonide) injected into a joint space allowed
* At least 4 weeks since prior local control or palliative radiotherapy and recovered
* Recovered from prior major surgery
Exclusion criteria:
* More than 3 brain metastases
* Metastatic lesions greater than 2 cm
* Concurrent radiotherapy
* Prior radiotherapy to measurable disease
* Concurrent surgery
* Concurrent corticosteroids
* Concurrent topical or systemic steroids
* Concurrent chemotherapy
* Prior vaccination with any of the study peptides
* Recent (within the past year) or concurrent addiction to alcohol or illicit drugs
* Pregnant or nursing
* Known or suspected major allergy to any components of the study vaccine
* Significant detectable infection
* Immunosuppression conditions
* Prior or active autoimmune disorder requiring cytotoxic or mmunosuppressive therapy, except for any of the following:
* Presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody (ANA) titer) without symptoms
* Clinical evidence of vitiligo or other forms of depigmenting illness
* Mild arthritis requiring nonsteroidal anti-inflammatory medication
* Autoimmune disorder with visceral involvementReferences
Publications (0)
Data not yet available
No reference posted for this study.