Clinical trial · Interventional
Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Treatment of Patients With Metastatic Melanoma by Lymphodepleting Conditioning Followed by Infusion of TCR-Gene Engineered Lymphocytes and Subsequent Fowlpox gp100 Vaccination
- 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: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining gene-modified white blood cell infusions with interleukin-2 and vaccine therapy may kill more tumor cells. PURPOSE: This phase I trial is studying how well giving gene-modified white blood cells when given together with interleukin-2 and vaccine therapy works 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| gp100-fowlpox vaccine | Biological | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
| therapeutic tumor infiltrating lymphocytes | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Metastatic disease * Measurable disease * Refractory to standard therapy, including high-dose interleukin-2 therapy * HLA-A\*0201 positive * Progressive disease during prior immunization to melanoma antigens OR prior treatment with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) cellular therapy with or without myeloablation allowed provided toxicity resolved to ≤ grade 2 (except vitiligo) AND patient does not require systemic steroids * No brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL * Lymphocyte count \> 500/mm\^3 * WBC \> 3,000/mm\^3 * No coagulation disorders Hepatic * AST and ALT \< 3 times upper limit of normal (ULN) * Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL in patients with Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C antibody negative (unless antigen negative) Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * LVEF ≥ 45% by cardiac stress test * No LVEF \< 45% in patients ≥ 50 years of age * No myocardial infarction * No cardiac arrhythmias * No symptomatic cardiac ischemia * No prior EKG abnormalities * No other major cardiovascular illness Pulmonary * FEV\_1 ≥ 60% of predicted AND no obstructive or restrictive pulmonary disease * No symptoms of respiratory dysfunction * No other major respiratory illness Immunologic * HIV negative * Epstein-Barr virus positive * No active systemic infections (including opportunistic infections) * No form of primary (e.g., autoimmune colitis or Crohn's disease) or secondary immunodeficiency (due to chemotherapy or radiotherapy) * No prior severe immediate hypersensitivity reaction to any of the study agents including eggs * No other major illness of the immune system Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 month after study participation * Willing to complete a durable power of attorney (DPA) PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 6 weeks since prior MDX-010 Chemotherapy * Not specified Endocrine therapy * See Disease Characteristics * No concurrent systemic steroid therapy Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since other prior systemic therapy and recovered
References
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