Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox

• Sponsor: University of Louisville (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02009384
• Collaborator: James Graham Brown Cancer Center (Other)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 33
• Patients Per Site Per Month: 0.1

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
Metastatic Melanoma	Drug: Ipilimumab	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

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Open-Label Study of Ipilimumab Administered to Stage IIIC and Stage IV Melanoma Patients After Regulatory T Cell Depletion With Denileukin Diftitox
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

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

1. 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

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female patients ≥18 years of age;

2. Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);

3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;

4. Life expectancy ≥3 months;

5. Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;

6. At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);

7. 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.

1. 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;

2. 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;

3. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

Exclusion Criteria:

1. Prior treatment with Ipilimumab;

2. Known hypersensitivity to Ipilimumab or any of its components;

3. Steroids within one week prior to initiation of Ipilimumab.

4. Pre-existing autoimmune colitis.

5. Patients with an allograft requiring immunosuppression;

6. Known positive human immunodeficiency virus (HIV)

7. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;

8. 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.

• Responsible Party: Jason Chesney, Director, James Graham Brown Cancer Center, University of Louisville
• ClinicalTrials.gov Identifier: NCT02009384
• Other Study ID Numbers: BCC-MEL-11-01
• First Posted: Dec 12, 2013
• Last Update Posted: Oct 25, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Melanoma; Ipilimumab

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

1. Primary Outcome

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
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

[Not Specified]

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.