Clinical trial · Interventional
Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma
Randomized Phase II Trial of Autologous Vaccines Consisting of Adjuvant GM-CSF Plus Proliferating Tumor Cells Versus GM-CSF Plus Dendritic Cells Loaded With Proliferating Tumor Cells in Patients With Metastatic Melanoma (MAC-VAC)
- 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. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for melanoma. PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens to compare how well they work when given together with GM-CSF in treating patients with recurrent or 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous tumor cell vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive irradiated autologous tumor cells subcutaneously (SC) and sargramostim (GM-CSF) SC once weekly for 3 weeks and then once monthly for up to 5 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: autologous tumor cell vaccine
- Biological: sargramostim
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive autologous dendritic cells loaded with irradiated autologous tumor cells SC and GM-CSF SC once weekly for 3 weeks and then once monthly for up to 5 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: sargramostim
- Biological: therapeutic autologous dendritic cells
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Regionally recurrent or distant metastatic disease * Must have an established continuously proliferating cell line expanded to about 200 million cells that is free of stromal cells and contamination * No active CNS metastases * Prior treatment for brain metastases or spinal cord compression allowed * No clear evidence of disease progression in the CNS * No concurrent pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 70-100% OR ECOG PS 0-1 * Platelet count \> 100,000/mm³ * Hematocrit \> 30% * Creatinine \< 2.0 mg/dL * Bilirubin \< 2.0 mg/dL * Albumin \> 3.0 mg/dL * No significant hepatic or renal dysfunction * No other invasive cancer within the past 5 years * No active infection or other active medical condition that could be eminently life threatening, including any of the following: * Active blood clotting * Bleeding diathesis * No ongoing transfusion requirement * No underlying cardiac disease associated with known myocardial dysfunction * No unstable angina related to atherosclerotic cardiovascular disease * No known autoimmune disease * Negative pregnancy test PRIOR CONCURRENT THERAPY: * Prior surgery, radiotherapy, chemotherapy, biological therapy (including sargramostim \[GM-CSF\]), or vaccine therapy allowed * No concurrent anticancer therapy (e.g., hormone therapy for prostate or breast cancer) * No concurrent digoxin or other medications for the treatment of heart failure * No concurrent immunosuppressive therapy
References
Publications (3)
- DERIVEDNistor GI, Dillman RO. Cytokine network analysis of immune responses before and after autologous dendritic cell and tumor cell vaccine immunotherapies in a randomized trial. J Transl Med. 2020 Apr 21;18(1):176. doi: 10.1186/s12967-020-02328-6. PMID 32316978
- DERIVEDDillman RO, Cornforth AN, McClay EF, Depriest C. Patient-specific dendritic cell vaccines with autologous tumor antigens in 72 patients with metastatic melanoma. Melanoma Manag. 2019 May 31;6(2):MMT20. doi: 10.2217/mmt-2018-0010. PMID 31406564
- DERIVEDDillman RO, Cornforth AN, Depriest C, McClay EF, Amatruda TT, de Leon C, Ellis RE, Mayorga C, Carbonell D, Cubellis JM. Tumor stem cell antigens as consolidative active specific immunotherapy: a randomized phase II trial of dendritic cells versus tumor cells in patients with metastatic melanoma. J Immunother. 2012 Oct;35(8):641-9. doi: 10.1097/CJI.0b013e31826f79c8. PMID 22996370