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Sarcoma

Lenalidomide in Treating Patients With AIDS-Related Kaposi's Sarcoma (2507)
A Phase I/II Study of Lenalidomide in Patients with AIDS-Associated Kaposi's Sarcoma
Status Conditions Phase Study ID
Closed Sarcoma Phase I/II 2507.00
NCT01057121
Summary

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide and to see how well it works in treating patients with AIDS-related Kaposi sarcoma.


Investigator
Corey Casper
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

DISEASE CHARACTERISTICS:

  • Biopsy-confirmed Kaposi sarcoma (KS) involving skin with or without visceral involvement

    • Newly diagnosed or refractory to or intolerant of one or more prior therapies
  • 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

    • Patients should have a sufficient number of non-indicator lesions available for biopsy of a size that will permit four 3-mm tumor biopsies during the study (two biopsies will be performed on Day 1 prior to treatment and two biopsies will be performed on Day 15) (the two biopsies can be performed on two separate non-indicator lesions measuring > 4 mm OR performed on one non-indicator lesion measuring >8 mm in size)
  • No evidence of improvement in KS within the past 3 months, unless there is evidence of progression of KS within the past 4 weeks
  • No requirement for front-line therapy (i.e., symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status)
  • Serologically confirmed HIV infection by any of the FDA-approved tests

    • CD4 count > 50/mm^3 AND viral load < 2,000 copies/mL
    • Must be on a stable antiretroviral therapy regimen for HIV infection for ≥ 12 weeks before study entry

      • Any FDA-approved antiretroviral therapy (except for zidovudine) allowed

        • Patients whose antiretroviral regimen contains zidovudine and whose viral load is suppressed (viral load ≤ 200 copies/mL) are eligible provided their antiretroviral therapy is adjusted to a less toxic therapy not containing zidovudine (study enrollment may proceed without waiting 12 weeks)
        • Patients whose antiretroviral regimen contains zidovudine and whose viral load is not suppressed (viral load ≥ 200 copies/mL) are eligible provided their antiretroviral therapy is adjusted to a less toxic regimen not containing zidovudine AND they are stable for ≥ 12 weeks before study entry (allowing for optimal viral suppression)

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 3 months
  • Hemoglobin ≥ 8 g/dL (transfusion independent)
  • ANC ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Calculated creatinine clearance ≥ 60 mL/min (for patients enrolled in phase I) OR ≥ 30 mL/min (for patients enrolled in phase II)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3.5 mg/dL for patients with elevated bilirubin secondary to atazanavir therapy provided the direct bilirubin is normal)
  • AST and ALT ≤ 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study treatment
  • Able to comply with study treatment, in the opinion of the investigator
  • No other primary malignancy within the past 2 years except for basal cell skin cancer, cervical carcinoma in situ, or anal carcinoma in situ
  • No other neoplasia requiring cytotoxic therapy
  • No pulmonary embolism (PE) or deep vein thrombosis (DVT) within the past year

    • History of PE or DVT or predisposing clotting risk factors are allowed provided patient is receiving anticoagulation at therapeutic dosing
  • No acute infection (other than oral thrush or genital herpes) requiring treatment within the past 14 days
  • No concurrent, acute, active opportunistic infection (other than oral thrush or genital herpes) within the past 14 days
  • No other serious medical illness within the past 14 days
  • No physical or psychiatric condition that, in the opinion of the investigator, would place the patient at high-risk of toxicity or non-compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior local therapy for any KS-indicator lesion unless the lesion has clearly progressed since treatment

    • Any prior local treatment to indicator lesions (regardless of the elapsed time) is not allowed unless there is evidence of clear-cut progression of that lesion(s)
  • More than 4 weeks since prior and no other concurrent antineoplastic treatment for KS (including chemotherapy, radiotherapy, local therapy [including topical fluorouracil], biological therapy, or investigational therapy)
  • No concurrent steroid treatment except steroids as replacement therapy for adrenal insufficiency or inhaled steroids for the treatment of asthma
  • No concurrent zidovudine
  • Concurrent erythropoietin-stimulating agents allowed provided patient is on therapeutic anticoagulation
Exclusions (conditions that would prevent participation in this study)

Other exclusion criteria may apply.

Last Updated
June 20, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.