Clinical trial · Interventional
Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes in Treating Patients With Metastatic Melanoma
Tumor Infiltrating Lymphocytes (TIL Cells) Transduced With An Interleukin-2 (SBIL-2) Gene Following The Administration Of A Nonmyeloablative But Lymphocyte Depleting Regimen in Metastatic Melanoma
- 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: Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for interleukin-2 into a person's tumor infiltrating lymphocytes may make the body build an immune response to kill tumor cells. Combining cyclophosphamide and fludarabine with gene-modified tumor cells may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gene-modified tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and to see how well they work in patients with metastatic melanoma (phase I is closed to accrual 3/29/06).
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 |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| interleukin-2 gene | Biological | — | UNRESOLVED |
| therapeutic tumor infiltrating lymphocytes | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival
Secondary outcomes (2)
- measure
- Clinical tumor regression
- measure
- Toxicity profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Metastatic disease * Refractory to standard therapy including high-dose interleukin-2 (IL-2) therapy * Evaluable disease * Patients may enroll at the cell infusion stage provided they have tumor available for biopsy OR expandable SBIL-2-transduced tumor infiltrating lymphocytes available * Progressive disease during prior immunization to melanoma antigens or cellular therapy, with or without myeloablation, allowed * Symptomatic CNS lesions allowed provided immediate active treatment for symptomatic lesions has been completed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count greater than 1,000/mm\^3 * WBC greater than 3,000/mm\^3 * Lymphocyte count greater than 500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL * No coagulation disorder Hepatic * Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome) * AST/ALT less than 3 times upper limit of normal * Hepatitis B surface antigen negative * Hepatitis C virus negative Renal * Creatinine no greater than 1.6 mg/dL Cardiovascular * No myocardial infarction * No cardiac arrhythmias * No abnormal stress thallium or comparable test * LVEF \> 45% and normal stress cardiac test in patients with the following criteria: * 50 years old or greater * History of EKG abnormalities, symptoms of cardiac ischemia or arrhythmias * No major cardiovascular illness Pulmonary * No obstructive or restrictive pulmonary disease * No major respiratory illness * FEV\_1 \> 60% predicted in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction Immunologic * HIV negative * No prior severe immediate hypersensitivity reaction * No primary or secondary immunodeficiency * No active systemic infection * No concurrent opportunistic infection * No major immune system illness Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after study therapy * Must sign a durable power of attorney PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior anti-cytotoxic T-lymphocyte antibody-4 antibody (CTLA-4) allowed unless post-MDX010 treatment and colonoscopy with colonic biopsies are normal Chemotherapy * Recovered from prior chemotherapy Endocrine therapy * No concurrent steroids Radiotherapy * Recovered from prior radiotherapy Surgery * Not specified Other * More than 4 weeks since prior systemic therapy
References
Publications (0)
Data not yet available