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Melanoma

Investigator(s):
Udai Kammula, M.D. Principal Investigator Phone: 301-435-8606 kammulau@mail.nih.gov
Referral Contact(s):
Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

Diagnosis of metastatic melanoma
Measurable disease
Refractory to treatment with high-dose aldesleukin, if medically eligible to receive it

Patients with ocular melanoma are not required to be refractory to high-dose aldesleukin

Must have gp100:154-162-reactive peripheral blood lymphocytes available (via leukapheresis performed on another Surgery Branch protocol)
HLA-A*0201 positive
Recovered from prior therapies (except for toxicities such as alopecia or vitiligo)
> 6 weeks since prior ipilimumab (MDX-010)

Patients who were previously treated with MDX-010 must have a normal colonoscopy with normal colonic biopsies

No concurrent systemic steroids
ECOG performance status 0–1 (for patients treated in the high-dose aldesleukin cohort) OR ECOG 0–2 (for patients treated in the low-dose aldesleukin cohort)
ANC > 1,000/mm³ (without filgrastim [G-CSF] support)
WBC > 3,000/mm³
Hemoglobin > 8.0 g/dL
Platelet count > 100,000/mm³
ALT and AST ≤ 2.5 x upper limit of normal (ULN)
Creatinine ≤ 1.6 mg/dL
Total bilirubin ≤ 2.0 mg/dL (< 3 mg/dL in patients with Gilbert’s syndrome)
HIV negative
Hepatitis B surface antigen or hepatitis C antibody negative
Not pregnant or nursing: fertile patients must use effective contraception during and for 4 months after receiving the preparative regimen
Physically able to tolerate nonmyeloablative chemotherapy
FEV₁ > 60% predicted in patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction (for patients treated in the high-dose aldesleukin cohort)
LVEF > 45% (for patients treated in the high-dose aldesleukin cohort)
No history of coronary revascularization or ischemic symptoms (for patients treated in the high-dose aldesleukin cohort)
No medical condition that would preclude study participation
No primary immunodeficiency disease
No history of severe immediate hypersensitivity reaction to any of the agents used in this study

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 (PBL) infusion:

Patients receive autologous gp100:154-162-reactive 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)

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)

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

This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
There is no charge for medical care received at NIH Clinical Center.

PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/5/08
Updated: 5/27/08