Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma (NCT01057121) | Clinical Trial Compass
CompletedPhase 1/2
Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma
United States38 participantsStarted 2010-08-27
Plain-language 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.
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:
* Biopsy-proven KS involving skin with or without visceral involvement either newly diagnosed or refractory to or intolerant of one or more prior therapies
* Patients must have cutaneous lesion(s) amenable to four 3 mm tumor biopsies during the study (either 4 separate lesions measuring \> 4 mm each OR 2 separate lesions measuring \> 8 mm each) and at least five additional lesions measurable for assessment with no improvement over the past month
* Serologic documentation of HIV infection by any of the Food and Drug Administration (FDA)-approved tests
* Karnofsky performance status \>= 60%
* Hemoglobin \>= 8 g/dL
* Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3
* Platelet count \>= 100,000/mm\^3
* Calculated (method of Cockcroft-Gault) creatinine clearance (CrCl) \>= 60 mL/min in the Phase I and CrCl \>= 30 mL/min in the Phase II (creatinine clearance may also be obtained by the 24-hour collection method at the investigator's discretion)
* Total bilirubin should be =\< 1.5x upper limit of normal (ULN); if, however, the elevated bilirubin is felt to be secondary to Atazanavir therapy, patients will be allowed to enroll on protocol if the total bilirubin is =\< 3.5 mg/dL provided that the direct bilirubin is normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3x ULN
* Life expectancy \>= 3 months
* Ability and willingness to g…
What they're measuring
1
Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)
Timeframe: 28 days
2
Tumor Response Rate
Timeframe: Up to 30 days after completion of study treatment