Melanoma Metastatic
Conditions
Keywords
Metastatic Melanoma
Brief summary
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage
Detailed description
In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (\> 1440 million IU/m2/year).
Interventions
DRUGInterleukin-2
Interleukin-2
Sponsors
Western Regional Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated. 2. Patients must have bi-dimensional measurable disease on physical exam or radiologic studies. 3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months. 4. White blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, ALT, AST \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl. 5. Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial. 6. Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded. 7. Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy. 8. Patient consent must be obtained prior to entrance onto study. 9. Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
Exclusion criteria
1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate. 2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy. 3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2. 4. Lactation or pregnancy. 5. Evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident. 6. Current brain metastasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Measured until Disease Progression or death from any cause up to 2 years | Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Duration of Response | Measured until Disease Progression or death from any cause up to 2 years | Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors \[RECIST\] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions. |
| Median Survival | From time of study entry until death, up to 10 years | Measured from date of entry on study until date of death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Number of Participants Treated with Interleukin-2 | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Number of Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Response Rate
Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).
Time frame: Measured until Disease Progression or death from any cause up to 2 years
Population: Data not collected
Secondary
Median Duration of Response
Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors \[RECIST\] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.
Time frame: Measured until Disease Progression or death from any cause up to 2 years
Population: Data not collected
Secondary
Median Survival
Measured from date of entry on study until date of death
Time frame: From time of study entry until death, up to 10 years
Population: Data was not collected