Trials / Completed
CompletedNCT01807182
Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma
Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion With Cyclophosphamide and Fludarabine for Patients With Metastatic Melanoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well tumor-infiltrating lymphocytes (TIL) after combination chemotherapy works in treating patients with melanoma that has spread to other places in the body. Biological therapies, such as TIL, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TIL after combination chemotherapy may kill more tumor cells.
Detailed description
OUTLINE: Patients receive cyclophosphamide intravenously (IV) on days -7 to -6 and fludarabine phosphate IV on days -5 to -1. Patients undergo TIL infusion over 30-60 minutes on day 0 and receive aldesleukin IV every 8 hours on days 1-5 for up to a maximum of 14 doses. After completion of study treatment, patients are followed up at 6, 12, and 24 weeks.
Conditions
- Stage III Cutaneous Melanoma AJCC v7
- Stage IIIA Cutaneous Melanoma AJCC v7
- Stage IIIB Cutaneous Melanoma AJCC v7
- Stage IIIC Cutaneous Melanoma AJCC v7
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Metastatic Melanoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Aldesleukin | Given IV |
| DRUG | Cyclophosphamide | Given IV |
| DRUG | Fludarabine Phosphate | Given IV |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| BIOLOGICAL | Therapeutic Tumor Infiltrating Lymphocytes | Undergo TIL infusion |
Timeline
- Start date
- 2013-08-20
- Primary completion
- 2021-08-26
- Completion
- 2021-08-26
- First posted
- 2013-03-08
- Last updated
- 2022-11-10
- Results posted
- 2022-11-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01807182. Inclusion in this directory is not an endorsement.