Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective treatment for metastatic melanoma.

PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide together with autologous lymphocytes and aldesleukin and to see how well it works in treating patients with metastatic melanoma.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cyclophosphamide

Criteria

Inclusion Criteria

• Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease.

• 18 to 75 years of age and able to tolerate high-dose cyclophosphamide

• Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan).

• For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal ECG, any history of cardiac disease, a family history of cardiac disease, hypercholesterolemia or hypertension.

• For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):

• Pulse: >45 or < 120

• Weight: >45 kg

• Temperature: <38C (<100.4 F)

• WBC: >3,000

• HCT: >30%

• Platelets: >100,000

• ADDITIONAL INCLUSION CRITERIA FOR T CELL INFUSION

Exclusion Criteria

• Significant cardiovascular abnormalities as defined by any one of the following:

• congestive heart failure,

• clinically significant hypotension,

• symptoms of coronary artery disease,

• presence of cardiac arrhythmias on EKG requiring drug therapy

• ejection fraction < 50 % (echocardiogram or MUGA)

• Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy.