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

NCT03596918 | Completed Results

• 3 other identifiers: AMC-S007NCI-2017-01864UM1CA121947
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AIDS-Related Kaposi Sarcoma; Human Immunodeficiency Virus 1 Positive

Outcome Measures

Primary Outcomes (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

  Up to 3 months after treatment completion

Other Outcomes (1)

• Clinical Data Collection Quality for Site Evaluation and Training Purposes

  Up to 1 year

Study Arms (1)

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.

Biological: Bleomycin Sulfate; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate

Interventions

Bleomycin Sulfate BIOLOGICAL

Given IV

Also known as: Blanoxan, BleMomycine, Blenoxane, Bleo-cell, Bleo-S, Bleocin, Bleolem, Bleomycin Sulfas, Bleomycin Sulphate, Blexane, Oil Bleo

Supportive care (vincristine sulfate, bleomycin sulfate)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (vincristine sulfate, bleomycin sulfate)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (vincristine sulfate, bleomycin sulfate)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (vincristine sulfate, bleomycin sulfate)

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Leurocristine sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Supportive care (vincristine sulfate, bleomycin sulfate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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,

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator
• University of Arkansas: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Bugando Medical Centre

Mwanza, Tanzania

Location

MeSH Terms

Conditions

AIDS-related Kaposi sarcoma

Interventions

Bleomycin; Vincristine

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Dr. Jeannette Y. Lee
• Organization: AMC Statistical and Data Analysis Center

jylee@uams.edu

(501) 526-6712

Study Officials

• Kristin Schroeder

  AIDS Malignancy Consortium

  STUDY CHAIR

• Nestory Masalu

  Bugando Medical Centre

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: October 10, 2018
• Primary Completion: June 13, 2020
• Study Completion: June 13, 2020
• Last Updated: February 11, 2026
• Results First Posted: July 25, 2022

Record last verified: 2026-01

Locations

TA (1)