Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00085423|
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : April 10, 2013
Last Update Posted : April 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: aldesleukin Biological: sargramostim Drug: cyclophosphamide Drug: fludarabine phosphate||Phase 2|
- Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2.
- Determine the feasibility of this regimen in these patients.
- Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen.
- Determine time to disease progression and survival in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days 1 and 2 and fludarabine IV over 30 minutes on days 3-7. Patients then receive high-dose interleukin-2 IV every 8 hours (14 doses) on days 8-12 and 22-26. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 8 and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||February 2010|
U.S. FDA Resources
Experimental: IL-2, CTX, fludarabine, GM-CSF
Aldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
‡Interleukin-2 (aldesleukin) IV (600,000 U/kg; Chiron, Emeryville, CA): two 5-day courses on days 8 and 22. Interleukin-2 was given over 15 minutes every 8 hours. Goal is 14 doses/5-day course
Other Name: Aldesleukin; IL-2; HD IL-2; Interleukin-2Biological: sargramostim
GM-CSF was given subcutaneously daily from day 8 until absolute granulocyte count exceeds 5,000 cells/mL for 2 consecutive days.
Other Name: GM-CSF; granulocyte-macrophage colony-stimulating factorDrug: cyclophosphamide
Cyclophosphamide (60 mg/kg/d; Baxter, Deerfield, IL) intravenously (IV) for 2 days with sodium 2- mercaptoethanesulfonate (Mesna; Sicor, Irvine, CA) at 20% of cyclophosphamide dose IV 15 minutes before and 40% of the cyclophosphamide dose orally at 2 and 6 hours after the initiation of chemotherapy.
Other Name: cyclophosphamide,CytoxanDrug: fludarabine phosphate
Fludarabine IV (25 mg/M2/day)-five daily doses from Day 3
Other Name: Fludara
- Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST [ Time Frame: Response at 12 weeks ]Objective response as measured by radiological and physical examination using RECIST criteria.
- Number of Participants With Lymphocyte Recovery as Measured by Blood Count [ Time Frame: on days 1-15, weekly for 2 weeks, and then every 2-3 months ]Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame.
- Time to Progression as Measured by RECIST [ Time Frame: From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months ]Clinical outcome used the National Cancer Institute's Response Evaluation Criteria in Solid Tumors (RECIST)1.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085423
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Marc S. Ernstoff, MD||Norris Cotton Cancer Center|