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Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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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 SupportBethesda, Maryland  20892-1182