Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

August 31, 1999

Primary Completion Date

May 31, 2010

Study Completion Date

May 31, 2010

Conditions
MelanomaNeoplasm Metastasis
Interventions
DRUG

gp100:209-217 (210M)

"gp100 = gp100:209-217(210M) peptide - 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus gp100:209-217(210M) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.~MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections."

DRUG

Montanide ISA-51

MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.

DRUG

IL-2

"125,000 IU/kg dose intravenous for 5 days for 6 weeks with 2 days rest per week.~720,000 IU/kg intravenous every 8 hours for a maximum of 12 doses."

DRUG

MART-1:26-35(27L)

MART-1 = MART-1:26-35(27L) peptide- 1 mg in IFA SQ (in the subcutaneous tissue of each thigh) on the morning of the cell infusion, plus MART-1:26-35(27L) peptide, 1 mg, in IFA injected into the subcutaneous tissue in two equal volumes, 1.0 mL for each injection, within 2cm of each other, in the thigh daily for five days starting on the morning of the cell infusion and then weekly for 3 more injections.

BIOLOGICAL

Abl cells

Abl cells IV = Lymphocytes 10\^9-10\^11 IV over 30 minutes on day 0, repeated in 14 to 21 days Abl cells IA = Lymphocytes 10\^9-10\^11 IA over 30 minutes on day 0, repeated in 14 to 21 days

DRUG

Fludarabine

5x25 mg/m\^2 intravenous

DRUG

Cyclophosphamide

2x30 mg/kg, 2x60 mg/kg intravenous

BIOLOGICAL

GCSF (Growth colony stimulating factor)

Beginning on day 1 or 2, GCSF will be administered subcutaneously at a dose of 5mcg/kg/day (not to exceed 300 mcg/day. Filgrastim administration will continue daily until neutrophil count \> 1.0 x10\^9/L x 3 days or \> 5.0 x10\^9/L.

PROCEDURE

Apheresis

Trial Locations (1)

20892

National Cancer Institute (NCI), Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00001832 - Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma | Biotech Hunter | Biotech Hunter