Clinical trial · Interventional
Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma
NCT00317759CI-TRIAL-00019279completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Stage IV disease * HLA-A2 or -A3-expressing disease * Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan) * No CNS metastases * Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 80-100% Life expectancy * More than 6 months Hematopoietic * Platelet count \> 100,000/mm\^3 * Absolute neutrophil count \> 2,000/mm\^3 Hepatic * SGOT no greater than 3 times upper limit of normal * Bilirubin no greater than 1.6 mg/dL * INR no greater than 1.5 times normal Renal * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * No congestive heart failure * No clinically significant hypotension * No symptoms of coronary artery disease * No cardiac arrhythmia by EKG requiring drug therapy Pulmonary * No clinically significant pulmonary dysfunction * FEV\_1 at least 1.0 L\* * DLCO at least 45%\* NOTE: \*For patients with a history of pulmonary dysfunction Immunologic * No active infection * No oral temperature greater than 38.2°C within the past 48 hours * No systemic infection requiring chronic maintenance or suppressive therapy Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy) Chemotherapy * At least 3 weeks since prior chemotherapy (standard or experimental) Endocrine therapy * No concurrent steroids Radiotherapy * At least 3 weeks since prior radiotherapy Surgery * Not specified Other * At least 3 weeks since prior immunosuppressive therapy * No concurrent pentoxifylline * No other concurrent investigational agents
References
Publications (1)
- RESULTWallen H, Thompson JA, Reilly JZ, Rodmyre RM, Cao J, Yee C. Fludarabine modulates immune response and extends in vivo survival of adoptively transferred CD8 T cells in patients with metastatic melanoma. PLoS One. 2009;4(3):e4749. doi: 10.1371/journal.pone.0004749. Epub 2009 Mar 9. PMID 19270751