Clinical trial · Interventional
Laboratory-Treated Autologous Lymphocytes and Aldesleukin After Cyclophosphamide and Fludarabine in Treating Patients With Metastatic Melanoma
A Phase II Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen in Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): administrative decision- PI retired and treating physician left the institution
Summary
Brief summary (as posted)
RATIONALE: Treating lymphocytes in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving laboratory-treated lymphocytes and aldesleukin together with cyclophosphamide and fludarabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well laboratory-treated autologous lymphocytes and aldesleukin work when given after cyclophosphamide and fludarabine 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Infiltrating Lymphocytes (TIL) | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Determine toxicity of treatment regimen.
- interventionNames
- Biological: Tumor Infiltrating Lymphocytes (TIL)
Primary outcomes (1)
- measure
- Primary Objective
- timeFrame
- 4-6 weeks after completion of TIL
- description
- Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Refractory to standard treatment including high-dose aldesleukin (IL-2), unless previously ineligible for or refused IL-2 * Measurable disease with ≥ 1 lesion that is resectable for tumor-infiltrating lymphocyte generation * Patients with ≥ 1 brain metastases \< 1 cm each, or 1-2 brain metastases \> 1 cm are eligible provided they have been treated and stable for ≥ 3 months PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 3 months * ANC \> 1,000/mm\^3 (without filgrastim support) * WBC \> 3,000/mm\^3 * Hemoglobin \> 8.0 g/dL * Platelet count \> 100,000/mm\^3 * Serum ALT/AST \< 3 times upper limit of normal * Total bilirubin ≤ 2 mg/dL (\< 3 mg/dL in patients with Gilbert's syndrome) * Serum creatinine ≤ 1.6 mg/dL * LVEF \> 45% in patients meeting the following criteria: * Clinically significant atrial and/or ventricular arrhythmias, including, but not limited to, atrial fibrillation, ventricular tachycardia, or second- or third-degree heart block * At least 60 years of age * FEV\_1 \> 60% in patients meeting the following criteria: * Prolonged history of cigarette smoking * Symptoms of respiratory dysfunction * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after completion of study treatment * No HIV or hepatitis B or C positivity * No form of primary immunodeficiency (e.g., severe combined immunodeficiency disease or AIDS) * No opportunistic infections * No active systemic infections * No history of severe immediate hypersensitivity reaction to any of the agents used in this study * No coagulation disorders * No myocardial infarction, cardiac arrhythmias, or positive stress thallium or comparable test * No history of coronary revascularization or ischemic symptoms * No obstructive or restrictive pulmonary disease * No other active major medical illness of the cardiovascular, respiratory, or immune system PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy (alopecia or vitiligo allowed) * At least 6 weeks since prior ipilimumab * Must have normal colonoscopy with normal colonic biopsies * At least 4 weeks since prior systemic therapy * Minor surgical procedures within the past 3 weeks allowed provided all toxicities have recovered to ≤ grade 1 * No concurrent systemic steroids * No other concurrent experimental agents
References
Publications (0)
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