Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma
NCT00107159CI-TRIAL-00012533completedPhase 2ClinicalTrials.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 a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
Secondary outcomes (2)
- measure
- Safety
- measure
- Immune response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages:
* Stage IIIB or IIIC disease
* Unresected, in-transit lymph node metastases (N2c or N3)
* Stage IV disease
* Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b)
* No cerebral, bone, or other visceral metastases
* At least 1 measurable or evaluable lesion
* Small-volume multiple cutaneous deposits allowed
* Progressive disease, as defined by 1 of the following criteria:
* At least 20% increase in size in ≥ 1 measurable or evaluable lesion
* Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
Hepatic
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
* Lactic dehydrogenase normal
* No active hepatitis B or C infection
Renal
* Creatinine ≤ 1.5 times ULN
Immunologic
* No history of autoimmune disease
* Vitiligo allowed
* No history of immunodeficiency syndrome
* No active bacterial, viral, or fungal infection within the past 72 hours
* HIV-1 or -2 negative
* Human T-cell lymphotrophic virus-I or -II negative
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No contraindication to apheresis
* No other significant medical or surgical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior vaccine therapy with ≥ 1 melanoma antigen or peptide
* More than 4 weeks since prior biologic therapy
Chemotherapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
* No concurrent chronic systemic corticosteroids
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* More than 4 weeks since prior investigational products
* More than 4 weeks since prior chronic systemic immunosuppressive treatment
* No concurrent medication or treatment regimen that would prelude study participation
* No other concurrent anticancer treatment
* No other concurrent immunosuppressive treatmentReferences
Publications (1)
- RESULTRibas A, Camacho LH, Lee SM, Hersh EM, Brown CK, Richards JM, Rodriguez MJ, Prieto VG, Glaspy JA, Oseguera DK, Hernandez J, Villanueva A, Chmielowski B, Mitsky P, Bercovici N, Wasserman E, Landais D, Ross MI. Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. J Transl Med. 2010 Sep 27;8:89. doi: 10.1186/1479-5876-8-89. PMID 20875102