Trial Outcomes & Findings for Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions (NCT NCT00026793)

Last Updated: 2020-07-08

Results Overview

Temperature in KS lesions compared to normal skin either adjacent to the lesion or on the contralateral side was measured with thermography (thermal energy). A higher temperature is proportional to the severity of the lesion (worst outcome). A reduction in temperature is consistent with a decrease in severity of the lesions (better outcome).

Recruitment status

COMPLETED

Target enrollment

29 participants

Primary outcome timeframe

Baseline (prior to therapy)

Results posted on

2020-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Kaposi's Sarcoma Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
Overall Study STARTED	29
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Kaposi's Sarcoma Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
Overall Study Death on study due to underlying disease	4
Overall Study Physician Decision	2
Overall Study Off study	2

Baseline Characteristics

Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kaposi's Sarcoma n=29 Participants Adult patients with biopsy-proven cutaneous Kaposi's sarcoma
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	54.69 years STANDARD_DEVIATION 8.38 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (prior to therapy)

Population: Only 16/29 participants were analyzed for this outcome measure. Due to the assay being developed, results data were not collected in a consistent manner for the remaining 13 participants.

Outcome measures

Outcome measures
Measure	Kaposi's Sarcoma n=16 Participants Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
Preliminary Assessment of the Temperature of Kaposi's Sarcoma Lesions Compared to the Temperature in the Normal Skin Measured With Thermography	1.1 Celsius Interval -0.68 to 3.43

SECONDARY outcome

Timeframe: Baseline (prior to therapy)

Population: Only 16/29 participants were analyzed for this outcome measure. Due to the assay being developed, results data were not collected in a consistent manner for the remaining 13 participants.

Outcome measures

Outcome measures
Measure	Kaposi's Sarcoma n=16 Participants Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
Preliminary Assessment of the Blood Velocity in Kaposi's Sarcoma (KS) Lesions Compared to That in the Surrounding Area	66 Arbritary units (AU) Interval -44.0 to 451.0

SECONDARY outcome

Timeframe: Baseline and 18 weeks after therapy

Population: Only 10/29 participants were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Kaposi's Sarcoma n=10 Participants Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
Preliminary Assessment of the Temperature Change in Kaposi Sarcoma Lesions at Week 18 of Therapy Compared to Baseline as Measured With Thermography	-0.985 Celsius Interval -2.99 to 0.4

SECONDARY outcome

Timeframe: Baseline and 18 weeks after therapy

Population: Only 10/29 participants were analyzed for this outcome measure.

Blood velocity in Kaposi's Sarcoma lesions as compared to the surrounding area was measured with laser doppler imaging with a low power laser beam. Higher velocity is an indication of more severe lesions. The value at week 18 is compared to the baseline value for each subject, and the difference reported.

Outcome measures

Outcome measures
Measure	Kaposi's Sarcoma n=10 Participants Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
Preliminary Assessment of the Change in Blood Velocity in Kaposi's Sarcoma Lesions Measured With Laser Doppler Imaging Before and After Therapy	-115 Change in arbritary units (AU) Interval -305.0 to -17.0

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 196 months and 19 days.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Kaposi's Sarcoma n=29 Participants Adult patients with biopsy-proven cutaneous Kaposi's sarcoma. Some participants received interleukin-12 and liposomal doxorubicin. However, the therapy was administered on a different protocol and was not part of this study.
Number of Participants With Serious and Non-serious Adverse Events	0 Participants

Adverse Events

Kaposi's Sarcoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Yarchoan

National Cancer Institute

Phone: 240-760-6075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place