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

AIDS-Related Kaposi Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596918
• Other study ID #: AMC-S007
• Secondary ID: NCI-2017-01864AM
• Status: Completed
• Start date: October 10, 2018
• Est. completion date: June 13, 2020

Study information

• Verified date: July 2022
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

PRIMARY OBJECTIVES:

I. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 13, 2020
• Est. primary completion date: June 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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,

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS-Related Kaposi Sarcoma
• HIV Infections
• Human Immunodeficiency Virus 1 Positive
• Sarcoma
• Sarcoma, Kaposi

Intervention

Biological:
• Bleomycin Sulfate
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Drug:
• Vincristine Sulfate
Given IV

Locations

Country	Name	City	State
Tanzania	Bugando Medical Centre	Mwanza

Sponsors (5)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas, University of California, Los Angeles

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Data Collection Quality for Site Evaluation and Training Purposes		Up to 1 year
Primary	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