Trial Outcomes & Findings for Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma (NCT NCT00085423)

Results Overview

Objective response as measured by radiological and physical examination using RECIST criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Response at 12 weeks

Results posted on

2013-04-10

Participant Flow

recruitment was open from February 2004 to December 2008.

Participant milestones

Participant milestones
Measure	Lymphodepleting Chemotherapy + High Dose Interleukin-2 Lymphodepleting chemotherapy + high dose interleukin-2: Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lymphodepleting Chemotherapy + High Dose Interleukin-2 Lymphodepleting chemotherapy + high dose interleukin-2: Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
Overall Study Withdrawal by Subject	1
Overall Study screen failure	1

Baseline Characteristics

Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lymphodepleting Chemotherapy + High Dose IL-2 n=20 Participants intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). GM-CSF (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	52 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Response at 12 weeks

Population: Response was determined by physical examination and radiologic testing. Percent of the total number of patients treated was calculated.

Objective response as measured by radiological and physical examination using RECIST criteria.

Outcome measures

Outcome measures
Measure	Group 1 n=18 Participants all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST	3 participants

SECONDARY outcome

Timeframe: on days 1-15, weekly for 2 weeks, and then every 2-3 months

Population: each patient's differential blood counts were used to determine the time of recovery to the lower limit of normal lymphocytes in the peripheral blood.

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.

Outcome measures

Outcome measures
Measure	Group 1 n=18 Participants all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
Number of Participants With Lymphocyte Recovery as Measured by Blood Count	18 participants Interval 1000.0 to 4000.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 n=18 Participants all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
Time to Progression as Measured by RECIST	.3 years Interval 0.2 to 0.4

Adverse Events

Group 1

Serious events: 8 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=18 participants at risk all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
Blood and lymphatic system disorders anemia	44.4% 8/18 • Number of events 18 • 4 years

Other adverse events

Other adverse events
Measure	Group 1 n=18 participants at risk all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
Blood and lymphatic system disorders thrombocytopenia	22.2% 4/18 • Number of events 18 • 4 years

Additional Information

Dr. Marc Ernstoff

Dartmouth-Hitchcock

Phone: 603 650 5534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place