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Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma

Studies

Study First Submitted Date 2022-06-06
Study First Posted Date 2022-06-09
Last Update Posted Date 2023-05-23
Start Month Year March 15, 2024
Primary Completion Month Year December 2027
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-23

Browse Interventions

Sequence: 96283162 Sequence: 96283163 Sequence: 96283164 Sequence: 96283165 Sequence: 96283166 Sequence: 96283167 Sequence: 96283168 Sequence: 96283169 Sequence: 96283170 Sequence: 96283171 Sequence: 96283172 Sequence: 96283173 Sequence: 96283174
Mesh Term Paclitaxel Mesh Term Doxorubicin Mesh Term Liposomal doxorubicin Mesh Term Antineoplastic Agents, Phytogenic Mesh Term Antineoplastic Agents Mesh Term Tubulin Modulators Mesh Term Antimitotic Agents Mesh Term Mitosis Modulators Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antibiotics, Antineoplastic Mesh Term Topoisomerase II Inhibitors Mesh Term Topoisomerase Inhibitors Mesh Term Enzyme Inhibitors
Downcase Mesh Term paclitaxel Downcase Mesh Term doxorubicin Downcase Mesh Term liposomal doxorubicin Downcase Mesh Term antineoplastic agents, phytogenic Downcase Mesh Term antineoplastic agents Downcase Mesh Term tubulin modulators Downcase Mesh Term antimitotic agents Downcase Mesh Term mitosis modulators Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antibiotics, antineoplastic Downcase Mesh Term topoisomerase ii inhibitors Downcase Mesh Term topoisomerase inhibitors Downcase Mesh Term enzyme inhibitors
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52319051 Sequence: 52319052
Name Kaposi Sarcoma Name HIV-1-infection
Downcase Name kaposi sarcoma Downcase Name hiv-1-infection

Id Information

Sequence: 40264307 Sequence: 40264308
Id Source org_study_id Id Source secondary_id
Id Value AMC-114 Id Value U01CA121947
Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/U01CA121947

Design Groups

Sequence: 55757815 Sequence: 55757816
Group Type Active Comparator Group Type Active Comparator
Title Pegylated Liposomal Doxorubicin Title Paclitaxel
Description Participants will receive a single intravenous dose of PLD 20 mg/m2 once every 3 weeks for a total of 18 weeks. Description Participants will receive a single intravenous dose of PTX 100 mg/m2 once every 3 weeks for a total of 18 weeks.

Interventions

Sequence: 52630021 Sequence: 52630022
Intervention Type Drug Intervention Type Drug
Name Pegylated liposomal doxorubicin Name Paclitaxel
Description PLD 20 mg/m2 on Day 1 of every 21-day cycle Description PTX 100 mg/m2 on Day 1 of every 21-day cycle

Keywords

Sequence: 80072916 Sequence: 80072917 Sequence: 80072918 Sequence: 80072919 Sequence: 80072920
Name Paclitaxel Name Pegylated liposomal doxorubicin Name AIDS associated Kaposi Sarcoma Name Human Immunodeficiency Virus Name HIV-related Kaposi Sarcoma
Downcase Name paclitaxel Downcase Name pegylated liposomal doxorubicin Downcase Name aids associated kaposi sarcoma Downcase Name human immunodeficiency virus Downcase Name hiv-related kaposi sarcoma

Design Outcomes

Sequence: 177925191 Sequence: 177925192 Sequence: 177925193 Sequence: 177925194
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Progression Free Survival at 48 weeks Measure Frequency and severity of adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in participants receiving PLD or PTX. Measure Objective response rate for AIDS-related KS in patients receiving PLD and PTX Measure Duration of Response in patients receiving PLD and PTX
Time Frame 48 weeks Time Frame 96 weeks Time Frame 96 weeks Time Frame 96 weeks
Description Progression free survival (PFS) is defined as the length of time from enrollment into the study until disease progression or death. Disease progression will be assessed using the Kaposi Sarcoma Response Evaluation Criteria. Progressive disease is defined as: 1) 25% increase in the sum of perpendicular diameters of the indicator lesions; 2) 25% increase in the total number of KS lesions or the appearance of 5 new lesions; OR 3) 25% increase in the number of raised lesions Description The frequency of adverse events that occur in patients receiving PLD will be compared with the frequency of adverse events in patients receiving PTX Description The objective response rate is defined as the sum of the number of complete and partial responses in patients receiving PLD or PTX. Description Response duration is defined as the time from first documentation of complete or partial response as measured by KS response criteria to the documentation of first progression of disease as measured by KS response criteria

Browse Conditions

Sequence: 194049482 Sequence: 194049483 Sequence: 194049484 Sequence: 194049485 Sequence: 194049486 Sequence: 194049487 Sequence: 194049488 Sequence: 194049489 Sequence: 194049490 Sequence: 194049491
Mesh Term Sarcoma, Kaposi Mesh Term Sarcoma Mesh Term Neoplasms, Connective and Soft Tissue Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Herpesviridae Infections Mesh Term DNA Virus Infections Mesh Term Virus Diseases Mesh Term Infections Mesh Term Neoplasms, Vascular Tissue
Downcase Mesh Term sarcoma, kaposi Downcase Mesh Term sarcoma Downcase Mesh Term neoplasms, connective and soft tissue Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term herpesviridae infections Downcase Mesh Term dna virus infections Downcase Mesh Term virus diseases Downcase Mesh Term infections Downcase Mesh Term neoplasms, vascular tissue
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48457745 Sequence: 48457746
Agency Class NETWORK Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name AIDS Malignancy Consortium Name National Cancer Institute (NCI)

Central Contacts

Sequence: 12045586
Contact Type primary
Name Margaret Borok- Williams, MD
Phone +263 (242) 791-631
Email mborok@mweb.co.zw
Role Contact

Design Group Interventions

Sequence: 68348239 Sequence: 68348240
Design Group Id 55757815 Design Group Id 55757816
Intervention Id 52630021 Intervention Id 52630022

Eligibilities

Sequence: 30851030
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: HIV-1 infection. Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist. Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR Stage T0 KS that has progressed or not responded after a minimum of 12 weeks of treatment with ART. Participants with T0 KS must have either: 20 or more skin and/or oral KS lesions, and/or any number of lesions on exposed body areas that have an adverse effect on quality of life (e.g., stigmatization). Men and women ≥ 18 years. Because no dosing or adverse event data are currently available on the use of PTX or PLD for AIDS-KS in persons <18 years of age, children are excluded from this study Karnofsky performance status ≥ 60 (ECOG ≤ 2). Echocardiogram or Multiple gated acquisition scanning (MUGA) showing an ejection fraction ≥ 50%. Ability and willingness of participant or legal guardian to provide informed consent. Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen considered likely to result in HIV suppression. Measurable cutaneous KS, defined as follows: When available, a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be ≥ 700mm2. The following laboratory values obtained within 14 days prior to study entry: Absolute Neutrophil Count ≥ 1000 cells/mm3. Hemoglobin ≥ 8 g/dL (may be achieved with transfusion if clinically indicated, in the opinion of the investigator). Platelet count ≥ 75,000/mm3. ALT, AST, Alkaline phosphatase < 5 × upper limit of normal (ULN). Total bilirubin: ≤ 1.5 × ULN, unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be ≤ 2 x the ULN. Creatinine < institutional ULN OR estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. Women of reproductive potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months), must have a negative pregnancy test done within 24 hours of initiating the protocol-specified chemotherapy medication. Participants must agree to use two reliable forms of contraception simultaneously while receiving study protocol-specified medication and for 6 months after stopping the medication. Adequate venous access. No prior chemotherapy or use of systemic cytotoxic therapy agents. Participant is able to understand and willing to sign a written informed consent document. Exclusion Criteria: Current acute, chronic, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy before study entry and/or is not clinically stable. Serious illness necessitating hospitalization/systemic treatment within 14 days prior to study entry Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant. Known history of congestive heart failure and/or systolic ejection fraction < 50%. Prior radiotherapy to KS indicator lesions Prior or current immunotherapy Any immunomodulator, HIV vaccine, live attenuated vaccine, other investigational vaccine within 30 days prior to study entry, excluding vaccines against COVID-19/SARS-CoV-2, which are permitted. Known allergy/hypersensitivity to the study drug or its formulation Any condition, including the presence of laboratory abnormalities, which in the opinion of the responsible investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study. Corticosteroid use at doses above those given for replacement therapy for adrenal insufficiency within the last 30 days prior to study entry. Patients with psychiatric illness and/or social circumstances that would limit compliance with study requirements.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254266895
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30596888
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26740640 Sequence: 26740641
Intervention Id 52630021 Intervention Id 52630022
Name Doxil Name Taxol

Responsible Parties

Sequence: 28963368
Responsible Party Type Sponsor