Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox
Study Details
Study Description
Brief Summary
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ipilimumab IV ipilimumab |
Drug: Ipilimumab
administration of IV ipilimumab for up to 4 cycles
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline Using Immune-related Response Criteria (irRC) [baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks]
no outcomes available, Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female patients ≥18 years of age;
-
Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
-
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
-
Life expectancy ≥3 months;
-
Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
-
At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
-
Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
-
Absolute neutrophil count (ANC) ≥1.0 x 109/L;
-
Platelet count ≥100 x 109/L;
-
Hemoglobin ≥8 g/dL;
-
Serum creatinine ≤3 x upper limit of normal (ULN)
-
Total serum bilirubin ≤2 x ULN;
-
Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤2x ULN, and ≤3 x ULN if liver metastases are present.
-
Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
-
Pre-menopausal females and females <2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year;
-
Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
Exclusion Criteria:
-
Prior treatment with Ipilimumab;
-
Known hypersensitivity to Ipilimumab or any of its components;
-
Steroids within one week prior to initiation of Ipilimumab.
-
Pre-existing autoimmune colitis.
-
Patients with an allograft requiring immunosuppression;
-
Known positive human immunodeficiency virus (HIV)
-
Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
-
Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- University of Louisville
- James Graham Brown Cancer Center
Investigators
- Principal Investigator: Jason Chesney, MD, Brown Cancer Center, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCC-MEL-11-01
Study Results
Participant Flow
Recruitment Details | Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed |
---|---|
Pre-assignment Detail | Study was Terminated |
Arm/Group Title | Ipilimumab |
---|---|
Arm/Group Description | IV ipilimumab Ipilimumab: administration of IV ipilimumab for up to 4 cycles Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed |
Period Title: Overall Study | |
STARTED | 2 |
COMPLETED | 0 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Ipilimumab |
---|---|
Arm/Group Description | IV ipilimumab Ipilimumab: administration of IV ipilimumab for up to 4 cycles |
Overall Participants | 2 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
0
0%
|
>=65 years |
2
100%
|
Age (years) [Mean (Full Range) ] | |
Mean (Full Range) [years] |
67
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
2
100%
|
Region of Enrollment (participants) [Number] | |
United States |
2
100%
|
Outcome Measures
Title | Change From Baseline Using Immune-related Response Criteria (irRC) |
---|---|
Description | no outcomes available, Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed |
Time Frame | baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |
Outcome Measure Data
Analysis Population Description |
---|
no outcomes available, Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed |
Arm/Group Title | Ipilimumab |
---|---|
Arm/Group Description | IV ipilimumab Ipilimumab: administration of IV ipilimumab for up to 4 cycles Study was Terminated due to low subject enrollment [r/t requirement of prior treatment with denileukin diftitox] Data was not analyzed |
Measure Participants | 0 |
Adverse Events
Time Frame | All AEs During study treatment and 21 days following end of treatment will be documented and reported if applicable. Adverse events occurring between the time of signing informed consent to the date of the first dose will NOT be captured as AEs unless the AE is a direct result of a study-specific procedure or results in death from an event other than PD | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Ipilimumab | |
Arm/Group Description | dosage:3 mg/kg of subject weight dosage form: Intravenous administration on Ipilimumab frequency of administration: Ipilimumab: administration of IV ipilimumab every three weeks for up to 4 cycles | |
All Cause Mortality |
||
Ipilimumab | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Ipilimumab | ||
Affected / at Risk (%) | # Events | |
Total | 1/2 (50%) | |
Nervous system disorders | ||
Grade: 3 Encephalopathy | 1/2 (50%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Ipilimumab | ||
Affected / at Risk (%) | # Events | |
Total | 0/2 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jason Chesney |
---|---|
Organization | University of Louisville |
Phone | 502-562-3429 |
- BCC-MEL-11-01