At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of metastatic melanoma with measurable disease
- ✓Age 18 years or older
- ✓ECOG performance status 0-1
- ✓Life expectancy at least 3 months
- ✕Active major immunologic illness, systemic infections, or immunodeficiency
- ✕Hepatitis B or C
- ✕Coagulation disorders
- ✕Active major cardiovascular illness or myocardial infarction history
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy, Total Body Irradiation and Reconstitution With CD34+ Cells
In Brief
A Phase 2 clinical trial evaluating aldesleukin, filgrastim, and 4 other interventions for Melanoma (Skin). Completed, enrolled 34 participants across 2 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.
Study Details
Timeline
Interventions
high dose: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days (maximum 5 doses) or low dose: 250,000 IU/kg subcutaneously daily for 5 days, after a two day rest, 125,000 IU/kg subcutaneously daily for 5 days for five weeks (2 days rest per week)
10 mcg/kg/day daily subcutaneously until neutrophil count \>1x10\^9/1.
Lymphocytes that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
60 mg/kg/day x 2 days intravenously over 1 hour
25 mg/m\^2/day intravenous piggyback daily over 15-20 minutes for 5 days
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.