T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma.

Inge Marie Svane1 site in 1 country31 target enrollmentJune 2009

ConditionsMelanoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Melanoma
Sponsor: Inge Marie Svane
Enrollment: 31
Locations: 1
Primary Endpoint: toxicity
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.

Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.

After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

January 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Inge Marie Svane

Responsible Party

Sponsor Investigator

Principal Investigator

Inge Marie Svane

Professor

Herlev Hospital

Eligibility Criteria

Inclusion Criteria

•Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.

Exclusion Criteria

•Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.