malignant melanoma skin cancer
Conditions
Interventions
Pilot study:
Patients need to undergo surgery to obtain a metastasis of 3 cm (dm) that will
be used to culture TIL. Only when these cells can be cultured in vitro,
patients will be hospitalized for
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients must have metastatic melanoma with a resectable metastatic lesion of sufficient size (>= 3 cm) and must be willing to undergo such a resection for experimental purposes. • Patients must be >= 18 years of age and must have measurable metastatic melanoma (in addition to the resected lesion). • Patients must have a clinical performance status of ECOG 0 or 1. • Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regimen. • Patients must be able to understand and sign the Informed Consent document. • Hematology: Absolute neutrophil count greater than 1.5 x 10^9/L without support of filgrastim. Platelet count greater than 100 x 10^9/L. Hemoglobin greater than 5 mmol/L. • Chemistry Serum ALAT/ASAT less than 3 times the upper limit of normal, unless patients have liver metastases (
Exclusion criteria
Exclusion criteria: • Life expectancy of less than three months. • Patients with metastatic ocular or mucosal melanoma. • Requirement for systemic steroid therapy. • Patients who have a history of more than two CNS metastases. • Patients who have any CNS lesion that is symptomatic, greater than 1 cm in diameter or shows significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clinical or radiologic CNS progression for at least 2 months. • Any immunosuppressive chemotherapy or systemic steroid therapy within the last 3 weeks. • The following patients will be excluded because of inability to receive high dose interleukin-2: History of coronary revascularization Documented LVEF of less than 45% in patients with: o Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, 2° or 3° heart block Documented FEV1 less than or equal to 60% predicted for patients with: o A prolonged history of cigarette smoking (greater than 20 pack/year within the past 2 years) o Symptoms of respiratory distress • All patients* toxicities due to prior non-systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks. • Women who are pregnant or breastfeeding. • Any active systemic infections, coagulation disorders or other active major medical illnesses, such as active autoimmune disease requiring anti-TNF treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: Pilot study: To examine whether the logistics and timing of this complex treatment can be managed properly without delays for the patients. If necessary, this will be optimized before entering the RCT. In addition, the toxicity according CTC and response rate according RECIST 1.1 will be documented. Part II: Randomized controlled phase II study: Primary endpoint: Increase in median progression free survival from 2 to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Part II: Randomized controlled phase II study: Secondary endpoint: Objective response rate (RECIST), 1-year PFS, median overall survival, toxicity. | — |
Countries
Netherlands
Outcome results
None listed