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High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma



- Determine the objective response rate in lymphodepleted patients with metastatic
melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2.

- Determine the feasibility of this regimen in these patients.


- Determine the quality and quantity of lymphocyte recovery in these patients during and
after treatment with this regimen.

- Determine time to disease progression and survival in patients treated with this

OUTLINE: This is an open-label, multicenter study.

Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days
1 and 2 and fludarabine IV over 30 minutes on days 3-7. Patients then receive high-dose
interleukin-2 IV every 8 hours (14 doses) on days 8-12 and 22-26. Patients also receive
sargramostim (GM-CSF) subcutaneously beginning on day 8 and continuing until blood counts
recover. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.

Inclusion Criteria:

- Histologically confirmed melanoma

- Metastatic disease

- Measurable disease

- No history of brain metastases

- Over 18

- Karnofsky 60-100%

- Life expectancy At least 12 weeks

- Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 8.5 g/dL

- aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if
liver metastases are present)

- Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome)

- Hepatitis B and C negative

- Creatinine ≤ 2.0 times ULN

- Creatinine clearance ≥ 50 mL/min

- Cardiovascular

- Ejection fraction ≥ 50%

- No evidence of congestive heart failure

- No symptoms of coronary artery disease

- No serious cardiac arrhythmias

- No myocardial infarction within the past 6 months

- Cardiac stress test negative or of low probability for patients > 40 years of age OR
who have had prior myocardial infarction > 6 months ago

- Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for
height and age

- Diffusing capacity of lung for carbon monoxide ≥ 60%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

Exclusion Criteria:

- No uncontrolled diabetes

- No history of autoimmune disease

- No active infection

- No other concurrent significant illness that would preclude study participation

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder
cancer without local recurrence, or carcinoma in situ of the breast)

- At least 4 weeks since prior immunotherapy and recovered

- No other concurrent anticancer biologic agents

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No concurrent chemotherapy

- At least 4 weeks since prior steroid therapy

- No concurrent corticosteroids

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

- At least 4 weeks since prior surgery and recovered

- No concurrent immunosuppressive therapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Objective response as measured by radiological and physical examination using RECIST criteria.

Outcome Time Frame:

Response at 12 weeks

Safety Issue:


Principal Investigator

Marc S. Ernstoff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

February 2010

Related Keywords:

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



Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002