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AIDS-Related Kaposi SarcomaNCT03596918

Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine

An observational study of AIDS-Related Kaposi Sarcoma and Human Immunodeficiency Virus 1 Positive, run by AIDS Malignancy Consortium at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot phase I trial studies how well treatment with vincristine and bleomycin affect quality of life in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bleomycin Sulfate, Laboratory Biomarker Analysis and Quality-of-Life Assessment
Type of treatment
Injection or infusion
How many people
10 participants
Where
1 siteTanzania
Study dates
10 Oct 2018to 13 Jun 2020
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be selected from the clinical care population presenting to Bugando Medical Center.

Who may be able to join

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA) viral load
  • NOTE: the term "licensed" refers to a United States (U.S.) FDA-approved kit or for sites located in countries other than the U.S., a kit that has been certified or licensed by an oversight body within that country and validated internally
  • World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 ribonucleic acid (RNA) viral load
  • Participants must have pathologically confirmed Kaposi sarcoma
  • Participants should not have had prior therapy for their Kaposi sarcoma
  • All participants must be on stable antiretroviral therapy (ART) for a minimum of 12 weeks prior to study entry with an acceptable regimen that adheres to national guidelines for treatment of HIV infection
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  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky performance status >= 50%)
  • Leukocytes: >= 3,000/mm^3, within 7 days of enrollment
  • Absolute neutrophil count: >= 1,000/mm^3, within 7 days of enrollment
  • Hemoglobin >= 8 g/dL, within 7 days of enrollment
  • Platelets: >= 75,000/mm^3, within 7 days of enrollment
  • Direct bilirubin: < 3 mg/dL, within 7 days of enrollment
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]): =< 2.5 x institutional upper limit of normal, within 7 days of enrollment
  • Creatinine:
  • Creatinine levels within normal institutional limits, within 7 days of enrollment; or,
  • Creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal, within 7 days of enrollment
  • Participants with serious chronic, acute, or recurrent infections must have completed at least 14 days of therapy prior to study entry and be clinically stable
  • If the participant is a female of childbearing potential (FCBP), 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 in the preceding 24 consecutive months), the participant must have a negative urine or serum pregnancy test within 1 week prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), during the 5 months of planned chemotherapy treatment and for 6 months after completing treatment
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Participants who are receiving any other investigational agents
  • Participants with known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bleomycin or vincristine
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Participants who are breastfeeding a child; breastfeeding should be discontinued if the mother is treated with this chemotherapy
  • Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CT) scan, that, in the opinion of the investigator, would exclude bleomycin use
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  • NOTE: participants with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care; if available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent; these procedures should be completed outside the study; these participants should be excluded if, in the opinion of the site investigator, use of bleomycin would be detrimental
  • Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days before study enrollment
  • NOTE: exercise is defined as any activity that will increase a participant?s resting heart rate by at least 20 beats/minute

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Bugando Medical Centre

    Mwanza

Other trials in Tanzania

About this study

Official title: Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania

This pilot phase I trial studies how well treatment with vincristine and bleomycin affect quality of life in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the longitudinal quality of life of participants with human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS) during treatment with bleomycin sulfate (bleomycin) and vincristine sulfate (vincristine) at a single institution in East Africa.

SECONDARY OBJECTIVES:

II. To explore baseline and time-dependent correlates of improvements in quality of life (QOL).

TERTIARY OBJECTIVES:

III. To assess quality control (completeness and accuracy) in data capture of adverse events, clinical benefit, and objective response for site evaluation and training purposes.

OUTLINE:

Patients receive vincristine intravenously (IV) over 1-2 minutes and bleomycin IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 12 weeks.

Being tested
Bleomycin Sulfate, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Vincristine Sulfate
Medical subject headings
AIDS-related Kaposi sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bleomycin SulfateBiological

    Also called Blanoxan, BleMomycine, Blenoxane, Bleo-cell

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Vincristine SulfateDrug

    Also called Kyocristine, Leurocristine sulfate, Leurocristine, sulfate, Oncovin

    Given IV

Study groups in NCT03596918
Study groupRoleWhat they receive
Supportive care (vincristine sulfate, bleomycin sulfate)Patients receive vincristine sulfate IV over 1-2 minutes and bleomycin sulfate IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bleomycin Sulfate; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Score on Quality of Life Assessed Using Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire

    The four domains of the FACT-G questionnaire will be determined for each questionnaire: physical well-being, social/family well-being, emotional well-being, and functional well-being. Each of these four domains is scored on a subset of 6-7 statements with a 0-4 scale. The domain is scored by summing up the responses to these statements. The ranges for the domains are as follows: physical well-being 0-28, social/family well-being 0-28, emotional well-being 0-24, and functional well-being 0-28. Using general estimating equations, changes in these domains with time will be explored. Logistic regression analyses will be used to correlate changes in quality of life domains with clinical response.

    The overall score is the sum of all the subscales and ranges from 0 to 108. Higher scores reflect better quality of life outcomes.

    The FACT-G Total Score at 3 months is reported here

    Measured: Up to 3 months after treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2018
  2. Study start10 Oct 2018
  3. Primary completion13 Jun 2020
  4. Study completion13 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03596918
Sponsor's protocol ID
AMC-S007
Other IDs
NCI-2017-01864, AMC-S007, AMC-S007, UM1CA121947
Status last verified
Jan 2026
First submitted
13 Jul 2018
Last updated
11 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of AIDS-Related Kaposi Sarcoma and Human Immunodeficiency Virus 1 Positive, run by AIDS Malignancy Consortium at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Score on Quality of Life Assessed Using Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (time frame: Up to 3 months after treatment completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03596918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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