Clinical trial · Interventional
Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
Phase II Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low-Dose TBI, and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil (MMF) Followed by Donor Lymphocyte Infusion in Selected Patients With Metastatic Melanoma
- 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 fludarabine use 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. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells can reject the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, total-body irradiation, peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have stage IV 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 |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Partial response, minor response, or stable disease after no more than 2 regimens of chemotherapy, immunotherapy, or chemoimmunotherapy * Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging * HLA genotypically identical sibling donor available * Not an identical twin * Age 12 to 74 * No ocular melanoma * No active or untreated brain metastases or transmural gastrointestinal metastases PATIENT CHARACTERISTICS: Age: * 18 to 64 Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT and SGPT less than 2 times ULN Renal: * Creatinine clearance at least 40 mL/min Cardiovascular: * LVEF at least 40% if history of congestive heart failure * No uncontrolled hypertension Pulmonary: * DLCO at least 50% of predicted * No continuous supplementary oxygen Other: * Not pregnant * Fertile patients must use effective contraception during and for 1 year after study participation * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No concurrent growth factors during mycophenolate mofetil administration Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (0)
Data not yet available