Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma

NCT01057121 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-02-08

Study results available
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Summary

This phase I/II trial studies the side effects and best dose of lenalidomide and to see how well it works in treating patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma (KS). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.

Conditions

  • AIDS-Related Kaposi Sarcoma
  • Recurrent Kaposi Sarcoma

Interventions

DRUG

Lenalidomide

Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles. Sequential cohorts were entered at 10 mg/day, 15 mg/day, 20 mg/day and 25 mg/day using a 3+3 design to determine the MTD

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kelly Shimabukuro · AIDS Associated Malignancies Clinical Trials Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-27
Primary Completion
2014-08-04
Completion
2014-08-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057121 on ClinicalTrials.gov