Clinical trial · Interventional
Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma
NCT00085423CI-TRIAL-00009986completedPhase 2Results postedClinicalTrials.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: 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. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IL-2, CTX, fludarabine, GM-CSF
- description
- Aldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
- interventionNames
- Biological: aldesleukin
- Biological: sargramostim
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
Primary outcomes (1)
- measure
- Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST
- timeFrame
- Response at 12 weeks
- description
- Objective response as measured by radiological and physical examination using RECIST criteria.
Secondary outcomes (2)
- measure
- Number of Participants With Lymphocyte Recovery as Measured by Blood Count
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed melanoma * Metastatic disease * Measurable disease * No history of brain metastases * Over 18 * Karnofsky 60-100% * Life expectancy At least 12 weeks * Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL * aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome) * Hepatitis B and C negative * Creatinine ≤ 2.0 times ULN * Creatinine clearance ≥ 50 mL/min * Cardiovascular * Ejection fraction ≥ 50% * No evidence of congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * No myocardial infarction within the past 6 months * Cardiac stress test negative or of low probability for patients \> 40 years of age OR who have had prior myocardial infarction \> 6 months ago * Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age * Diffusing capacity of lung for carbon monoxide ≥ 60% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative Exclusion Criteria: * No uncontrolled diabetes * No history of autoimmune disease * No active infection * No other concurrent significant illness that would preclude study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast) * At least 4 weeks since prior immunotherapy and recovered * No other concurrent anticancer biologic agents * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent chemotherapy * At least 4 weeks since prior steroid therapy * No concurrent corticosteroids * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy * At least 4 weeks since prior surgery and recovered * No concurrent immunosuppressive therapy
References
Publications (1)
- RESULTGunturu KS, Meehan KR, Mackenzie TA, Crocenzi TS, McDermott D, Usherwood EJ, Margolin KA, Crosby NA, Atkins MB, Turk MJ, Ahonen C, Fuse S, Clark JI, Fisher JL, Noelle RJ, Ernstoff MS. Cytokine working group study of lymphodepleting chemotherapy, interleukin-2, and granulocyte-macrophage colony-stimulating factor in patients with metastatic melanoma: clinical outcomes and peripheral-blood cell recovery. J Clin Oncol. 2010 Mar 1;28(7):1196-202. doi: 10.1200/JCO.2009.24.8153. Epub 2010 Feb 1. PMID 20124177