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Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Non-Myeloablative But Lymphocyte Depleting Regimen

Phase 2
7 Years
Not Enrolling
Melanoma, Neoplasm Metastasis

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Trial Information

Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Non-Myeloablative But Lymphocyte Depleting Regimen

Patients with metastatic melanoma who are human immunodeficiency virus (HIV) and Hepatitis B
negative and who have previously progressed after receiving standard therapy will receive a
nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide
and fludarabine and then will be treated by the adoptive transfer of lymphocytes reactive
with shared antigens on their tumors. This study will evaluate the toxicity, immunologic
effects and potential therapeutic role of this treatment.

Inclusion Criteria


- Patients must have evaluable metastatic melanoma that is refractory to standard

- Age greater than or equal to 16 years.

- Patients of both genders must be willing to practice birth control for four months
after receiving the preparative regimen.

- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1 at
entry to the trial and at the time of chemotherapy induction.

- Absolute neutrophil count greater than 1000/mm^3.

- Platelet count greater than 100,000/mm^3.

- Hemoglobin greater than 8.0 g/dl.

- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than two
times the upper limit of normal.

- Serum creatinine less than or equal to 1.6 mg/dl.

- Total bilirubin less than or equal to 1.6 mg/dl, except for patients with Gilbert's
Syndrome who must have a total bilirubin less than 3.0 mg/dl.

- More than four weeks must have elapsed since any prior therapy at the time the
patient receives the preparative regimen.

- Women of child-bearing potential must have a negative pregnancy test because of the
potentially dangerous effects of the preparative chemotherapy on the fetus.

- Life expectancy of greater than three months.

- No steroid therapy required.

- Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental
treatment being evaluated in this protocol depends on an intact immune system.
Patients who are HIV seropositive can have decreased immune competence and thus be
less responsive to the experimental treatment and more susceptible to its

- Seronegative for hepatitis B antigen.

- Patients to receive high dose interleukin 2 (IL-2) must have no active systemic
infections, coagulation disorders or other major medical illnesses of the
cardiovascular, respiratory or immune system.

- Patients who will receive high dose IL-2 as part of the phase I portion of this study
or who will be randomized must be eligible to receive high dose IL-2.

- Any patient receiving IL-2 must sign a durable power of attorney.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Response

Outcome Description:

Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.

Outcome Time Frame:

Every three to four weeks after the treatment, for up to 5 years.

Safety Issue:


Principal Investigator

Steven Rosenberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, National Institutes of Health


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

May 2010

Related Keywords:

  • Melanoma
  • Neoplasm Metastasis
  • Immunotherapy
  • Adoptive Transfer
  • IL-2
  • Toxicity
  • Clinical Response
  • Breast Cancer
  • Neoplasms
  • Melanoma
  • Neoplasm Metastasis



National Cancer Institute (NCI) Bethesda, Maryland  20892