Study on Lymphodepletion and Cell Transfer with or without Dendritic Cell Immunization for Metastatic Melanoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT00338377

Provider View

This clinical trial is exploring whether adding dendritic cells to a treatment involving T cells and high-dose IL-2 can improve the persistence of T cells in patients with metastatic melanoma. The study also aims to evaluate tumor response and the effectiveness of T cells in targeting tumors.

Patient Parameters

Program Overview

The main goal of this study is to see if adding dendritic cells to a treatment with T cells and high-dose IL-2 helps the T cells last longer in the body compared to using T cells and IL-2 alone. Researchers will also look at how well the treatment works in shrinking tumors and if dendritic cells help T cells reach the tumor site. Additionally, the study will assess the characteristics of T cells that make them effective in fighting cancer. Different groups of patients will be studied to see how well they respond to the treatment and to confirm the safety of the treatment when T cells are introduced into the cerebrospinal fluid (CSF).

Eligibility Criteria

Inclusion Criteria

  • Have metastatic melanoma, uveal melanoma, or stage III in-transit or regional nodal disease.
  • Must have a brain scan (MRI/CT or PET/CT) within 6 months before joining the study.
  • Be 12 years or older.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Can have had previous treatments like immunotherapy or targeted therapy.
  • Must be HLA-A2 positive for certain parts of the study.
  • Have enough TIL (tumor-infiltrating lymphocytes) available for treatment.
  • Have measurable metastatic melanoma.
  • Can have small brain lesions (1 cm or smaller) or larger ones treated with SRS that are no longer active.
  • Must use birth control for four months after treatment.
  • Women must have a negative pregnancy test if they have had a period in the last year and haven't had sterilization surgery.
  • Must agree to use a reliable form of birth control during the study.
  • Must have certain blood counts and organ function levels.
  • Must have a stress cardiac test and pulmonary function tests within 6 months before treatment.
  • Must have a brain scan within 42 days before treatment.
  • Must be receiving a B-RAF inhibitor if in Cohort C.
  • Must have certain conditions related to brain and CSF involvement if in Cohort D.
  • Must be able to give informed consent and meet other health criteria.

Exclusion Criteria

  • Have had chemotherapy within four weeks before starting the treatment.
  • Have had B-RAF or MEK targeted therapy within 7 days before starting the treatment.
  • Not receiving B-RAF treatment if in Cohort C.
  • Achieved partial or complete response to B-RAF treatment if in Cohort C.
  • Pregnant or nursing women.
  • Have active infections needing IV antibiotics or major medical illnesses.
  • Have immune system deficiencies or need steroid therapy.
  • Have significant psychiatric conditions that affect consent or treatment safety.
  • Have rapidly advancing systemic or brain disease.
  • Pregnant patients in Cohort D.
  • Have rapidly declining neurological function.

Locations

FACILITYZIPCITYSTATE
The University of Texas MD Anderson Cancer Center77030HoustonTexas

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