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D0320: High Dose Interleukin-2 (IL-2) Therapy in "Lymphodepleted Primed" Patients With Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Metastatic Melanoma

Thank you

Trial Information

D0320: High Dose Interleukin-2 (IL-2) Therapy in "Lymphodepleted Primed" Patients With Metastatic Melanoma

After meeting eligibility requirements, patients will have outpatient chemotherapy,
cyclophosphamide for two days, fludarabine for five days, for a total of seven days. On the
eighth day, patients will be admitted to the hospital and receive Interleukin-2 and GM-CSF.
On the 22nd day, patients will be admitted to the hospital for a second course of
Interleukin-2. Including a post-treatment evaluation, treatment may last up to 27 weeks.

Inclusion Criteria:

- Histologically confirmed metastatic melanoma with measurable disease

- Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery
or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects

- Karnofsky Performance Status greater than or equal to 60%

- Life expectancy greater than or equal to 12 weeks

- Adequate end organ function as defined in text of protocol

- Women must not be pregnant or breastfeeding

- Must agree to use appropriate contraception

- Patient must be competent and must sign informed consent

Exclusion Criteria:

- Patients may not have been treated previously with IL-2

- Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive
cancer such as cervical CIS, superficial bladder cancer without local recurrence,
breast CIS

- In patients with a prior history of invasive malignancy, less than five years in
complete remission

- Positive serology for HIV, hepatitis B or hepatitis C

- Significant co-morbid illness such as uncontrolled diabetes or active infection that
would preclude treatment on this regimen

- Use of corticosteroids or other immunosuppression (if patient had been taking
steroids, at lease 4 weeks must have passed since the last dose)

- History of autoimmune disease

- Creatinine Clearance of less than 50ml/min

Type of Study:


Study Design:

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

Outcome Measure:

To determine complete and partial response rate

Outcome Time Frame:

From first day treatment to response

Safety Issue:


Principal Investigator

Marc S Ernstoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

March 2010

Related Keywords:

  • Metastatic Melanoma
  • Melanoma
  • Metastatic Melanoma
  • Interleukin-2
  • IL-2
  • Lymphodepletion
  • Melanoma



Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756