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Phase 2
17 Years
Not Enrolling
Melanoma (Skin)

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Trial Information


OBJECTIVES: I. Determine whether indomethacin given prior to tumor removal can increase the
number of tumor infiltrating lymphocytes (TIL) obtained from the tumor specimen of patients
with advanced melanoma. II. Determine the efficacy of administering concurrent indomethacin
to maximize immune effector cell function in situ during interleukin-2/TIL therapy in these
patients. III. Determine the relationship between the phenotypic character of TIL (generated
in culture from the patient's tumor) and the response to therapy. IV. Correlate the lytic
activity or lymphokine production of TIL (generated in culture from the patient's tumor)
with clinical response to therapy. V. Generate and use lymphokine-activated killer (LAK)
cells in those patients who do not have TIL available for therapy and evaluate LAK cells in
the same manner as TIL.

OUTLINE: Patients with resectable tumors and with adequate generation of TIL are treated on
Regimen A; those with unresectable tumors or insufficient TIL are treated on Regimen B. The
following acronyms are used: CTX Cyclophosphamide, NSC-26271 IL-2 Interleukin-2 (Cetus),
NSC-373364 LAK Lymphokine-Activated Killer Cells TIL Tumor Infiltrating Lymphocytes Regimen
A: Prostaglandin Inhibition Therapy plus Biological Response Modifier Therapy. Indomethacin;
plus CTX; IL-2-activated TIL; IL-2. Regimen B: Prostaglandin Inhibition Therapy plus
Biological Response Modifier Therapy. Indomethacin; plus IL-2-activated LAK; IL-2.

PROJECTED ACCRUAL: Up to 30 patients will be accrued over 3 years. If 0 of the first 10
patients, no more than 1 of the first 15 patients, or no more than 2 of the first 20
patients respond, accrual will cease.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically documented melanoma that is metastatic or
unresectable and unresponsive to conventional chemotherapy and/or radiotherapy Measurable
or evaluable disease required Measurable disease defined as bidimensionally measurable
lesion on physical exam, x-ray, or MRI Evaluable disease defined as: Unidimensionally
measurable lesion on x-ray, scan, or photograph Disease assessable by serial chemistries,
tumor markers, or nonspecific scans Disease assessable by functional manifestations (e.g.,
change in performance status, 10% or greater change in weight) Previously irradiated
lesion with subsequent disease progression documented Bone-only lesions may be considered
evaluable (lytic lesion on x-ray or bone scan should be followed) No metastases on CT or
MRI involving more than 50% of the liver No uncontrolled or untreated CNS metastases

PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG 0 or 1 Life expectancy: At
least 3 months Hematopoietic: (unless tumor involvement of bone marrow or spleen is
documented) WBC at least 3,500/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hemoglobin at least 11.5 g/dL No significant hematologic
abnormalities Hepatic: (unless tumor involvement of liver is documented) Bilirubin no
greater than 1.6 mg/dL SGOT no greater than 150 U/L PT at least 1.5 times control PTT less
than 1.5 times control Renal: (unless tumor involvement of kidney is documented)
Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min Calcium no
greater than 12 mg/dL No symptomatic hypercalcemia Cardiovascular: No myocardial
infarction within 6 months No congestive heart failure No edema No hypotension or
hypertension No coronary artery disease No history of arrhythmia No contraindication to
the use of pressor agents Pulmonary: FEV1 at least 65% of predicted Other: No significant
organ dysfunction No uncontrolled bacterial, viral, or fungal infection No active peptic
or duodenal ulcer No psychiatric or seizure disorder No prior solid organ allograft HIV
and hepatitis B surface antigen seronegative within 6 months of study entry No second
malignancy within 5 years except: Inactive nonmelanomatous skin cancer Carcinoma in situ
of the cervix No other serious illness that would limit survival to less than 2 years
Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since immunotherapy
Chemotherapy: Prior anthracyclines allowed provided no symptomatic heart disease is
present More than 4 weeks since chemotherapy (at least 2 weeks, with recovery, if disease
progression is documented) More than 6 weeks since nitrosoureas, melphalan, or mitomycin
Endocrine therapy: More than 1 week since corticosteroids (except physiological doses for
respiratory ailments or adrenal insufficiency) Radiotherapy: More than 4 weeks since
radiotherapy (at least 2 weeks, with recovery, if disease progression is documented)
Surgery: More than 3 weeks since major surgery (excluding surgery for tumor collection)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John P. Hanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Luke's Medical Center


United States: Federal Government

Study ID:




Start Date:

July 1993

Completion Date:

July 2004

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



St. Luke's Medical Center Milwaukee, Wisconsin  53215