Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma (NCT01016730) | Clinical Trial Compass
CompletedPhase 1
Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma
United States24 participantsStarted 2010-01-22
Plain-language summary
This pilot, phase I trial studies the side effects and best dose of bortezomib in treating patients with acquired immune deficiency syndrome (AIDS)-related Kaposi sarcoma that has come back or has not responded to treatment. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients with cutaneous AIDS-related biopsy-proven KS relapsed after or refractory to at least one other prior systemic therapy
* Patients must have cutaneous KS lesion(s) amenable to biopsy (either one lesion \>= 12 mm or 3 \>= 4 mm) in addition to at least 5 lesions measurable for assessment; all of these lesions must not have been previously radiated
* Must have been on stable anti-retroviral therapy for at least 12 weeks with a principal investigator (PI)-based or non-nucleoside reverse-transcriptase inhibitor (NNRTI)-based regimen of at least three drugs, with no intention to change the regimen for the duration of the study; patients who have a high likelihood of better HIV management with a new antiretroviral regimen should defer enrollment until the changes are in place and the new highly active antiretroviral therapy (HAART) regimen meets the 12 week criteria
* Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or other Food and Drug Administration (FDA)-approved licensed HIV test, or a detectable blood level of HIV RNA
* Women of child-bearing potential must have a negative pregnancy test within 72 hours before initiation of study drug dosing; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; male and female subjects of reproductive potential must agree to employ …
What they're measuring
1
MTD based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0