Clinical trial · Interventional
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy, Total Body Irradiation and Reconstitution With CD34+ Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic tumor infiltrating lymphocytes | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- TBI 200cGy + TIL +HD IL-2, prior IL-2
- description
- Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
- interventionNames
- Biological: aldesleukin
- Biological: filgrastim
- Biological: therapeutic tumor infiltrating lymphocytes
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Radiation: radiation therapy
- type
- OTHER
- label
- TBI 200cGy + TIL +HD IL-2, No prior IL-2
- description
- Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of metastatic melanoma
* Measurable disease
* Resected or stable brain metastases are allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Eastern Cooperative Oncology Group (ECOG) 0-1
Life expectancy
* At least 3 months
Hematopoietic
* See Immunologic
* Absolute neutrophil count \> 1,000/mm\^3 (without support of filgrastim \[G-CSF\])
* Platelet count \> 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL (transfusion allowed)
* No coagulation disorders
Hepatic
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 times upper limit of normal
* Bilirubin ≤ 2 mg/dL (\< 3 mg/dL in patients with Gilbert's syndrome)
* No hepatitis B or C
Renal
* Creatinine ≤ 1.6 mg/dL
Cardiovascular
* Left ventricular ejection fraction (LVEF) ≥ 45% by cardiac stress test\*
* No active major cardiovascular illness as evidenced by stress thallium or other comparable test
* No myocardial infarction
* No cardiac arrhythmias NOTE: \*For patients ≥ 50 years of age receiving high-dose interleukin-2 (IL-2) OR patients with a history of electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia, or arrhythmias
Pulmonary
* Forced expiratory volume 1 (FEV\_1) ≥ 60% of predicted by pulmonary function test in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction\*
* No active major respiratory illness
* No obstructive or restrictive pulmonary disease NOTE: \*For patients receiving high-dose IL-2 only
Immunologic
* No active major immunologic illness
* No active systemic infections
* No primary or secondary immunodeficiency
* Fully recovered immune competence after prior chemotherapy or radiotherapy as evidenced by both of the following:
* Absolute neutrophil count \> 1,000/mm\^3
* No opportunistic infections
* Human Immunodeficiency virus (HIV) negative
* Epstein-Barr virus positive
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* At least 6 weeks since prior nitrosourea therapy
* No prior cyclophosphamide and fludarabine as part of a preparative regimen on National Cancer Institute (NCI) Surgery Branch adoptive cell therapy studies unless sufficient numbers of CD34+ stem cells (more than 2 x10\^6/kg patient weight) have been obtained prior to the administration of chemotherapy
Endocrine therapy
* No concurrent systemic steroid therapy
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* Prior minor surgery within the past 3 weeks allowed if recovered
Other
* Recovered from all prior therapy
* At least 30 days since prior systemic therapy
* No other concurrent experimental agentsReferences
Publications (1)
- DERIVEDYao X, Ahmadzadeh M, Lu YC, Liewehr DJ, Dudley ME, Liu F, Schrump DS, Steinberg SM, Rosenberg SA, Robbins PF. Levels of peripheral CD4(+)FoxP3(+) regulatory T cells are negatively associated with clinical response to adoptive immunotherapy of human cancer. Blood. 2012 Jun 14;119(24):5688-96. doi: 10.1182/blood-2011-10-386482. Epub 2012 May 3. PMID 22555974