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AIDS-Related Kaposi SarcomaPhase 1/2NCT01057121

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

A Phase 1/2 study testing Lenalidomide in people with AIDS-Related Kaposi Sarcoma and Recurrent Kaposi Sarcoma, run by National Cancer Institute (NCI) at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
13 sitesUnited States
Study dates
27 Aug 2010to 4 Aug 2014
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 give informed consent
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to starting Cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide, during receipt of lenalidomide, and 28 days after discontinuation of lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
  • Patients must, in the opinion of the investigator, be capable of complying with the protocol
  • All patients must be on antiretroviral therapy for HIV infection with CD4 count > 50/mm^3 and viral load < 2,000 copies/mL; patients must be on a stable regimen for at least 12 weeks prior to study entry; patients may receive any FDA approved antiretroviral therapy except for zidovudine
  • There should be no evidence for improvement in KS in the 3 months prior to study entry, unless there is evidence for progression of KS in the 4 weeks immediately prior to study entry
  • If antiretroviral regimen contains zidovudine and viral load is suppressed (as measured by HIV viral load =< 200/mL), then antiretroviral therapy must be adjusted to a less toxic therapy not containing zidovudine and enrollment may proceed without waiting 12 weeks; if on zidovudine-containing therapy and viral load is not suppressed (as measured by HIV viral load >= 200/mL), then antiretroviral therapy must be adjusted to a less toxic regimen allowing for optimal viral suppression and must demonstrate stability for at least 12 weeks prior to study entry
  • Patients with any history of pulmonary embolism (PE) or deep venous thrombosis (DVT) or predisposing clotting risk factors must be on anticoagulation at therapeutic dosing

Who cannot join

  • Concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment
  • Patients for whom front-line cytotoxic therapy is indicated (i.e. symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status)
  • Concurrent neoplasia requiring cytotoxic therapy
  • Acute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within 14 days of study entry
  • Anti-neoplastic treatment for KS (including chemotherapy, radiation therapy, local therapy including topical 5-FU, biological therapy, or investigational therapy) within four weeks of study entry
  • Any steroid treatment except for that required for replacement therapy in adrenal insufficiency or inhaled steroids for the treatment of asthma
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  • Patient is =< 2 years free of another primary malignancy; exceptions include the following:
  • Basal cell skin cancer
  • Cervical carcinoma in situ
  • Anal carcinoma in situ
  • Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since treatment; any prior local treatment to indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion
  • Use of any investigational drug or treatment within 4 weeks prior to enrollment
  • Physical or psychiatric conditions that in the estimation of the investigator place the patient at high risk of toxicity or non-compliance
  • Female patients who are pregnant or breast-feeding
  • Patients with a history of DVT or PE within 1 year
  • Patients requiring blood transfusions to maintain Hgb eligibility
  • Patients on erythropoietin-stimulating agents (ESA) unless also on therapeutic anticoagulation
  • Patients with CD4 < 50 mm^3 and/or viral load > 2,000 copies/mL
  • Patients on estrogen therapy unless also on therapeutic anticoagulation

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

    Baltimore, Maryland, 21231

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Cancer Center of Hawaii-Hawaii AIDS Clinical Research Program

    Honolulu, Hawaii, 96816

  • Thomas Street Clinic

    Houston, Texas, 77009

  • UCLA Center for Clinical AIDS Research and Education

    Los Angeles, California, 90035

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • University of California San Diego

    San Diego, California, 92103

  • San Francisco General Hospital

    San Francisco, California, 94110

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Phase I/II Study of Lenalidomide in Patients With AIDS-Associated Kaposi's Sarcoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of single agent lenalidomide in subjects with AIDS-related KS. (Phase I) II. Evaluate the overall clinical response of KS tumors to lenalidomide with subset assessments of partial response (PR) and complete response (CR). (Phase II)

SECONDARY OBJECTIVES:

  1. Evaluate the effect of lenalidomide on human immunodeficiency virus (HIV) plasma viral loads.

II. Determine the effects of lenalidomide on T-lymphocyte subsets, including natural killer (NK) cells.

III. Evaluation of time to response, time to relapse, and time to death amongst subjects receiving lenalidomide.

IV. Determine the effect of lenalidomide on human herpesvirus (HHV)-8. V. Assess lenalidomide effects on HHV-8 copy number in peripheral blood mononuclear cell (PBMC), and plasma and whether changes in viral copy number measured in PBMC or plasma are associated with clinical response of KS tumors.

VI. Monitor HHV-8 gene expression in KS biopsy specimens and PBMC pre- and post-lenalidomide and assess whether changes in viral gene expression in tumor biopsy are associated with clinical response.

VII. Assess whether changes in viral copy number in the compartments assayed occur in concert or independently with changes in viral antigen expression in biopsy specimens.

VIII. Assess effects of lenalidomide on growth factors relevant to tumor proliferation (i.e., interleukin [IL]-1beta, IL-2, IL-4, IL-5, IL-6, IL-10, IL-15, IL-12p70, tumour necrosis factor [TNF]alpha, and interferon gamma [IFN]gamma).

IX. Characterize the effects of lenalidomide on viral and cellular gene in KS tumor biopsies.

  1. Assess changes in NK cell number (PBMC and tumor) and function pre- and post-lenalidomide.

XI. Assess the sensitivity and specificity of dermal adhesive strip samples to detect KS and the effects of lenalidomide on the lesions.

OUTLINE: This is a multicenter study. This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.

Patients receive lenalidomide orally (PO) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Being tested
Lenalidomide
Keywords
HIV Infections
Medical subject headings
AIDS-related Kaposi sarcoma, Sarcoma, Kaposi, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

    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

Study groups in NCT01057121
Study groupRoleWhat they receive
LenalidomideExperimentalPatients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Maximum tolerated dose (MTD) 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). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.

    Measured: 28 days

  2. Tumor Response Rate

    Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks.

    Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.

    Measured: Up to 30 days after completion of study treatment

Secondary outcomes (3)

  1. Time to Death

    Percentage of patients who died

    Measured: Up to 30 days after completion of study treatment

  2. Time to Relapse

    Percentage of participants who relapsed

    Measured: Up to 30 days after completion of study treatment

  3. Time to Response

    time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks.

    Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.

    Measured: Up to 30 days after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2010 (estimated)
  2. Study start27 Aug 2010
  3. Primary completion4 Aug 2014
  4. Study completion4 Aug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01057121
Sponsor's protocol ID
NCI-2012-02923
Other IDs
NCI-2012-02923, CDR0000664131, AMC-070, AMC-070, U01CA121947
Status last verified
Jan 2022
First submitted
26 Jan 2010
Last updated
8 Feb 2022
Data monitoring committee
Yes

Publications

  • Reid EG, Shimabukuro K, Moore P, Ambinder RF, Bui JD, Han S, Martinez-Maza O, Dittmer DP, Aboulafia D, Chiao EY, Maurer T, Baiocchi R, Mitsuyasu R, Wachsman W; AIDS Malignancy Consortium (AMC). AMC-070: Lenalidomide Is Safe and Effective in HIV-Associated Kaposi Sarcoma. Clin Cancer Res. 2022 Jun 13;28(12):2646-2656. doi: 10.1158/1078-0432.CCR-21-0645.

    PubMed 35247913

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide in people with AIDS-Related Kaposi Sarcoma and Recurrent Kaposi Sarcoma, run by National Cancer Institute (NCI) at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01057121, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

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