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Treatment of Metastatic Melanoma Patients With Tumor Infiltrating Lymphocytes and IL-2 Following a Regimen of Non-Myeloablative Lymphocyte Depleting Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

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Trial Information

Treatment of Metastatic Melanoma Patients With Tumor Infiltrating Lymphocytes and IL-2 Following a Regimen of Non-Myeloablative Lymphocyte Depleting Chemotherapy


Inclusion Criteria:



- Patients must have metastatic melanoma with a resectable metastatic lesion of
sufficient size and be willing to undergo such a resection for experimental purposes.
For HLA-A0201+ patients, lesions must be > 1.5 cm in diameter and for HLA-A0201-
patients, lesions must be > 3 cm in diameter.

- Patients must be > 18 years of age and must have measurable metastatic melanoma (in
addition to the resected lesion).

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

- Clinical performance status of ECOG 0, 1.

- Absolute neutrophil count greater than 1000/mm3 without support of filgrastim.

- Platelet count greater than 100,000/mm3.

- Serum ALT/AST less than three times the upper limit of normal.

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

- Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert's
Syndrome who must have a total bilirubin less than 3 mg/dl.

- Patients must be able to understand and sign the Informed Consent document

Exclusion Criteria:

- Tumor/TIL Harvest Exclusion Criteria:

- Less than 4 weeks has elapsed since any prior systemic therapy or less than six
weeks since prior nitrosourea therapy

- Women who are pregnant or breastfeeding because of the potentially dangerous
effects of the preparative chemotherapy on the fetus or infant.

- Life expectancy of less than three months.

- Patients who have received prior treatment with anti-CTLA-4 antibody will be
excluded unless a post anti-CTLA-4 antibody treatment colonoscopy was normal
with normal colonic biopsies.

- Patients who require immediate active treatment for symptomatic CNS lesions will
not be eligible until after treatment of their symptomatic lesions.

- Cell Infusion Exclusion Criteria:

- Less than 4 weeks has elapsed since any prior systemic therapy at the time the
patient receives the preparative regimen, or less than six weeks since prior
nitrosourea therapy. All patients' toxicities must have recovered to a grade 1
or less or as specified in the eligibility criteria. Patients may have
undergone minor surgical procedures or focal palliative radiotherapy (to
non-target lesions) within the past 4 weeks, as long as all toxicities have
recovered to grade 1 or less or as specified in the eligibility criteria.

- Women of child-bearing potential who are pregnant or breastfeeding because of
the potentially dangerous effects of the preparative chemotherapy on the fetus
or infant.

- Life expectancy of less than three months.

- Requirement for systemic steroid therapy.

- Hemoglobin less than 8g/dl unable to be corrected with transfusion.

- Any active systemic infections, coagulation disorders or other active major
medical illnesses of the cardiovascular, respiratory or immune system, as
evidenced by a positive stress thallium or comparable test, myocardial
infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.

- Any form of primary or secondary immunodeficiency. Must have recovered immune
competence after chemotherapy or radiation therapy as evidenced by normal ANC >
1000/mm3 and absence of opportunistic infections. (The experimental treatment
being evaluated in this protocol depends on an intact immune system. Patients
who have decreased immune competence may be less responsive to the experimental
treatment and more susceptible to its toxicities.)

- Seropositive for 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 are less responsive
to the experimental treatment and more susceptible to its toxicities.)

- Patients with hepatitis B or hepatitis C will be excluded.

- The following patients will be excluded because of inability to receive high dose
interleukin-2:

- Patients will be excluded if they have a history of major EKG abnormalities,
symptoms of cardiac ischemia or arrhythmias and have a LVEF < 45% on a cardiac
stress test (stress thallium, stress MUGA, dobutamine, echocardiogram or other
stress test)

- Similarly, patients who are 50 years old or greater with an LVEF < 45% will be
excluded

- Patients who have a prolonged history of cigarette smoking or symptoms of
respiratory dysfunction will be excluded if they have an abnormal pulmonary
function test as evidenced by a FEV1 < 60% predicted.

- Patients who have received prior treatment with anti-CTLA-4 antibody will be
excluded unless a subsequent colonoscopy was normal with normal colonic biopsies
(to rule out colitis).

- Patients who require immediate treatment for symptomatic CNS lesions will not be
eligible until after treatment of their symptomatic lesions and resolution of
symptoms.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate of this approach when administered in our hospital

Outcome Time Frame:

Two years

Safety Issue:

No

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

MS269- HMO-CTIL

NCT ID:

NCT00604136

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Metastatic Melanoma
  • melanoma
  • tumor infiltrating lymphocytes
  • interleukin-2
  • Melanoma

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