Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
OBJECTIVES:
- Determine whether reinfused activated cells alone or in conjunction with high or
subcutaneous dose interleukin-2 may result in clinical tumor regression in patients
with metastatic melanoma who had previously failed therapy on protocols involving
immunization against the gp100 molecule.
- Determine the survival of infused cells with antitumor activity in these patients.
OUTLINE: This is a salvage regimen.
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy
to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of
gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of
these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An
additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously
in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes.
At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may
be retreated.
Patients with disease progression after 2 courses may receive 2 additional courses of cell
infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients
receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after
cell infusion and continuing for up to 5 days of each treatment course. Another cohort
receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If
after 12-16 patients have been treated with cloned cells alone initially and responses are
inadequate, subsequent patients entered into this study are randomized to receive the cell
infusion followed by IL-2 on one of the two described schedules.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven metastatic melanoma that has failed therapy on protocols
involving immunization against the gp100 molecule
- Measurable or evaluable metastatic disease
- Must be HLA-A201 positive by standard HLA typing
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Greater than 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8.0 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT/AST less than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL
Cardiovascular:
- For patients randomized to receive interleukin-2:
- No major medical illnesses of the cardiovascular system
Pulmonary:
- For patients randomized to receive interleukin-2:
- No major medical illnesses of the pulmonary system
Other:
- HIV negative
- Hepatitis B antigen negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- For patients randomized to receive interleukin-2:
- No active systemic infection
- No other major medical illnesses of immune system
- No coagulation disorders
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- No concurrent steroid therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No concurrent active treatment of brain metastases
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Steven A. Rosenberg, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Surgery Branch
Authority:
United States: Federal Government
Study ID:
CDR0000066287
NCT ID:
NCT00019487
Start Date:
November 1998
Completion Date:
May 2003
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
