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

NCT ID: NCT01005537

Last Updated: 2010-08-06

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS
• Study Start Date: 2009-06-30

Brief 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.

Detailed Description

OBJECTIVES:

Primary

• Assess the safety and toxicity of cellular adoptive immunotherapy with autologous tumor-infiltrating lymphocytes (TIL) following cyclophosphamide conditioning and post-infusion aldesleukin (IL-2) in patients with metastatic melanoma.
• Assess the duration of in vivo persistence of adoptively transferred lymphocytes.

Secondary

• Evaluate the antitumor effect of adoptively transferred autologous TIL following cyclophosphamide conditioning and post-infusion IL-2 in these patients.

OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 and autologous tumor-infiltrating lymphocytes (TIL) IV on day 0. Beginning 6 hours after TIL infusion, patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14 doses) OR low-dose IL-2 subcutaneously twice daily on days 0-14 (for up to 28 doses). Patients may then receive two additional courses of TILs and low-dose IL-2 (with or without cyclophosphamide), if indicated.

After completion of study treatment, patients are followed up periodically.

Conditions

Melanoma (Skin)

Interventions

aldesleukin

Given IV and orally

Intervention Type: BIOLOGICAL

therapeutic autologous lymphocytes

Given IV

Intervention Type: BIOLOGICAL

cyclophosphamide

Given IV

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Fred Hutchinson Cancer Research Center

Principal Investigators

Cassian Yee, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Other Identifiers

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHCRC-2355.00

Identifier Type: -

Identifier Source: secondary_id

IR-6984

Identifier Type: -

Identifier Source: secondary_id

CDR0000648071

Identifier Type: REGISTRY

Identifier Source: secondary_id

2355.00

Identifier Type: -

Identifier Source: org_study_id