Melanoma – NCI-08-C-0104
Dr. Udai Kammula
Principal Investigator
NCI’s Center for Cancer Research (CCR) is currently conducting the following trial for patients with melanoma. Click on the trial below for additional details, including a summary of primary eligibility, study outline, and information on how to contact Dr. Kammula and his staff directly.
You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.
Lymphocyte-depleting preparative regimen:
- Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine phosphate IV over 30 minutes on Days -5 to -1
Autologous gp100-reactive peripheral blood lymphocyte infusion:
- Patients receive autologous gp100:154-162-reactive peripheral blood lymphocyte (PBL) IV over 20–30 minutes on Day 0
- Beginning on Day 1 or 2, patients receive filgrastim (G-CSF) subcutaneously (SC) once daily until blood counts recover
Aldesleukin:
- Patients are assigned to one of two aldesleukin treatment cohorts (depending on their eligibility to receive high-dose aldesleukin)
- Cohort I (high-dose aldesleukin):
- Patients receive high-dose aldesleukin IV over 15 minutes every 8 hours beginning within 24 hours after PBL infusion and continuing for up to 5 days (maximum of 15 doses)
- Cohort II (low-dose aldesleukin):
- Beginning within 24 hours after PBL infusion, patients receive low-dose aldesleukin SC once daily 5 days a week for up to 6 weeks
- Patients with a partial response to treatment or stable disease that subsequently progresses may receive up to one retreatment course (as above) beginning approximately 12 weeks after the last dose of aldesleukin
- After completion of study therapy, patients are followed every 1–6 months until disease progression
Why is this trial important?
Over the past decade, the incidence of melanoma in the United States has shown a dramatic increase. Melanoma is highly curable when identified and treated at in its earliest stage. However, there are very few therapeutic options when metastases develop. Immune-based therapies have shown recent promise. In pilot clinical trials, the adoptive transfer of autologous tumor-specific lymphocytes has demonstrated the ability to induce objective and durable clinical responses.
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