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

• ClinicalTrials.gov Identifier: NCT03596918
• Recruitment Status: Active, not recruiting
• First Posted: July 24, 2018
• Last Update Posted: February 11, 2020
• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); The Emmes Company, LLC; University of Arkansas; University of California, Los Angeles
• Information provided by (Responsible Party): AIDS Malignancy Consortium

Study Description

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.

Condition or disease	Intervention/treatment	Phase
AIDS-Related Kaposi Sarcoma; Human Immunodeficiency Virus 1 Positive	Biological: Bleomycin Sulfate; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania
• Actual Study Start Date: October 10, 2018
• Estimated Primary Completion Date: March 31, 2020
• Estimated Study Completion Date: March 31, 2020

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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; Given IV; Other Names: Blanoxan; BleMomycine; Blenoxane; Bleo-cell; Bleo-S; Bleocin; Bleolem; Bleomycin Sulfas; Bleomycin Sulphate; Blexane; Oil Bleo; Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Drug: Vincristine Sulfate; Given IV; Other Names: Kyocristine; Leurocristine sulfate; Leurocristine, sulfate; Oncovin; Vincasar; Vincosid; Vincrex; Vincristine, sulfate

Outcome Measures

Primary Outcome Measures :

1. Quality of life assessed using Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire [ Time Frame: Up to 3 months after treatment completion ]
   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.

Other Outcome Measures:

1. Clinical data collection quality for site evaluation and training purposes [ Time Frame: Up to 1 year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Tanzania

Bugando Medical Centre

Mwanza, Tanzania

Sponsors and Collaborators

AIDS Malignancy Consortium

National Cancer Institute (NCI)

The Emmes Company, LLC

University of Arkansas

University of California, Los Angeles

Investigators

• Study Chair: Kristin Schroeder; AIDS Malignancy Consortium
• Study Chair: Nestory Masalu; Bugando Medical Centre

More Information

• Responsible Party: AIDS Malignancy Consortium
• ClinicalTrials.gov Identifier: NCT03596918
• Other Study ID Numbers: AMC-S007; NCI-2017-01864 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); AMC-S007 ( Other Identifier: AIDS Malignancy Consortium ); AMC-S007 ( Other Identifier: CTEP ); UM1CA121947 ( U.S. NIH Grant/Contract )
• First Posted: July 24, 2018
• Last Update Posted: February 11, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Sarcoma, Kaposi; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Immunologic Deficiency Syndromes; Immune System Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases; Herpesviridae Infections; DNA Virus Infections; Neoplasms, Vascular Tissue; Vincristine; Bleomycin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antibiotics, Antineoplastic