Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With Unselected Autologous Amplified Tumor-RNA
NCT00126685CI-TRIAL-00012112unknownPhase 1 / Phase 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 tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous tumor cell vaccine | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Safety
- measure
- Immunogenicity
- measure
- Objective tumor response
- measure
- Time to disease progression
- measure
- Progression-free interval
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous melanoma\* * Stage IV disease (i.e., distant metastasis) * Not curable by surgical resection * NOTE: \*Metastatic melanoma with an unknown primary tumor allowed provided ocular melanoma can be definitely excluded and origin from the skin is likely * Unidimensionally or bidimensionally measurable disease by physical examination and/or noninvasive radiological procedures * At least 1 measurable metastasis that has not been previously excised or biopsied * Failed ≥ 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy) * At least 1 metastatic lesion surgically accessible\* for excision or biopsy to obtain tumor material for RNA isolation\*\* NOTE: \*Surgically accessible metastatic lesion not required provided properly processed tumor material or isolated tumor RNA is available from a metastasis excised or biopsied within the past 6 months NOTE: \*\*Major surgery not allowed for the acquisition of metastatic material solely for RNA isolation * No active CNS metastases by CT scan or MRI * Previously treated CNS metastases (e.g., by excision of a single metastasis, gamma knife radiosurgery, or stereotactic radiotherapy) allowed provided there is no evidence of active CNS metastasis by CT scan or MRI PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 60-100% Life expectancy * At least 4 months Hematopoietic * WBC \> 2,500/mm\^3 * Neutrophil count \> 1,000/mm\^3 * Lymphocyte count \> 700/mm\^3 * Platelet count \> 75,000/mm\^3 * Hemoglobin \> 9 g/dL * No bleeding disorders Hepatic * Bilirubin \< 2.0 mg/dL * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine \< 2.5 mg/dL Cardiovascular * No clinically significant heart disease Pulmonary * No respiratory disease Immunologic * HIV-1 or -2 negative * Human T-cell lymphotropic virus type I negative * No known hypersensitivity to dimethylsulfoxide * No immunodeficiency disease * No active systemic infection * No active autoimmune disease (except vitiligo), including any of the following: * Lupus erythematosus * Scleroderma * Rheumatoid arthritis (i.e., rheumatoid factor-positive arthritis with current or recent flare) * Ankylosing spondylitis * Autoimmune thyroiditis or uveitis * Autoimmune hemolytic anemia * Immune thrombocytopenic purpura * Multiple sclerosis * Inflammatory bowel disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use effective contraception during and for ≥ 4 weeks after completion of study treatment * Willing to undergo excision or biopsy of metastasis * Willing to be hospitalized for ≥ 24 hours after each vaccination * Medical condition stable * No contraindication to leukapheresis * No organic brain syndrome * No significant psychiatric abnormality that would preclude study participation * No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No other major serious illness PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 4 weeks since prior systemic immunotherapy * No systemic immunotherapy during and for 2 weeks after completion of study treatment Chemotherapy * See Disease Characteristics * More than 4 weeks since prior systemic chemotherapy * No systemic chemotherapy during and for 2 weeks after completion of study treatment Endocrine therapy * No systemic corticosteroids, including steroid-containing inhalers or chronic use of topical steroids over large areas of the body (if systemic effects are likely or obvious) during and for 2 weeks after completion of study treatment Radiotherapy * See Disease Characteristics * More than 2 weeks since prior radiotherapy * No prior radiotherapy to the spleen * Concurrent palliative radiotherapy to selected metastases for pain or local complications (e.g., compression) allowed Surgery * See Disease Characteristics * Recovered from prior surgery * No prior splenectomy * No prior organ allograft * Concurrent palliative surgery to selected metastases for pain or local complications (e.g., compression) allowed Other * Concurrent palliative hyperthermic therapy to selected metastases for pain or local complications (e.g., compression) allowed * No concurrent participation in any other clinical trial * No other systemic immunosuppressive agents (e.g., azathioprine or cyclosporine) during and for 2 weeks after completion of study treatment * No other investigational drugs or paramedical substances during and for 2 weeks after completion of study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.