Liposomal Doxorubicin and Interleukin-12 in Treating Patients With AIDS-Related Kaposi's Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020449
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill the tumor cells. Combining chemotherapy with interleukin-12 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with interleukin-12 in treating patients who have AIDS-related Kaposi's sarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Biological: recombinant interleukin-12 Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Phase 2

Detailed Description:


  • Determine the overall response rate in patients with AIDS-associated Kaposi's sarcoma (KS) treated with doxorubicin HCl liposome and interleukin-12.
  • Determine the time to response and the number of complete responses in patients treated with this regimen.
  • Determine the progression-free survival of patients treated with this regimen.
  • Provide pilot information on the ability of interleukin-12 to maintain major responses induced with paclitaxel salvage therapy in patients with aggressive or life-threatening KS after treatment failure with doxorubicin HCl liposome and interleukin-12.
  • Determine the effect of this regimen on CD4 counts and viral load in these patients.

OUTLINE: Patients receive doxorubicin HCl liposome (LipoDox) IV over 30 minutes once every 3 weeks for a total of 6 doses. Beginning concurrently with the initiation of LipoDox, patients also receive interleukin-12 (IL-12) subcutaneously twice weekly (at least 3 days apart) for up to 3 years.

Patients with refractory disease are transferred to the paclitaxel salvage therapy regimen comprising paclitaxel IV continuously on days 1-4 once every 3 weeks until a major response is achieved. Beginning concurrently with the initiation of paclitaxel salvage therapy, patients also receive IL-12 as above for up to 3 years.

Treatment continues in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response may discontinue IL-12 administration. If necessary, IL-12 treatment may resume at a later time.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2-4 years.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Liposomal Doxorubicin and Interleukin-12 in AIDS-Associated Kaposi's Sarcoma Followed by Chronic Administration of Interleukin-12
Study Start Date : January 2001
Actual Study Completion Date : May 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed Kaposi's sarcoma (KS)
  • HIV positive
  • Evaluable disease involving the skin and/or viscera

    • At least 5 lesions not previously treated with local therapy if restricted to the skin
    • Pulmonary lesions evaluable by CT scan
    • Gastrointestinal lesions evaluable by visualization or fiberoptic instrumentation
  • Presence of at least one of the following indications for cytotoxic chemotherapy:

    • Pulmonary involvement
    • Visceral involvement
    • Pain
    • Edema
    • Ulcerating lesions
    • Decreased range of joint motion due to KS
    • Multiple lesions not amenable to local therapy
    • Lymphedema that impairs mobility or range of motion
    • Significant psychological impact leading to social withdrawal
  • Progressive disease within the past 3 weeks while receiving a stable regimen of highly active antiretroviral therapy for at least 4 weeks unless there is a need for urgent chemotherapy
  • Prior participation on this study allowed, provided patient was removed from study due to non-pancreatic hyperamylasemia and the following are true:

    • No dose-limiting toxicity by clinical and laboratory assessment
    • Pancreatic amylase portion normal by fractionated amylase
    • Lipase normal
    • No symptoms referable to the pancreas



  • 18 and over

Performance status:

  • Karnofsky 30-100%

Life expectancy:

  • More than 2 months


  • Hemoglobin at least 9.0 g/dL
  • Absolute neutrophil count at least 750/mm^3
  • Platelet count at least 75,000/mm^3


  • Bilirubin no greater than 3.8 mg/dL with direct fraction no greater than 0.3 mg/dL and indirect fraction no greater than 3.5 mg/dL if due to protease inhibitor therapy
  • PT or aPTT no greater than 120% of control unless due to lupus-type anticoagulant
  • AST no greater than 2.5 times upper limit of normal
  • No prior hepatic cirrhosis
  • No hepatic dysfunction


  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min


  • No congestive heart failure
  • Ejection fraction at least 40% by MUGA or echocardiogram


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 2 months after study participation
  • No clinically significant autoimmune disease
  • No active, gross gastrointestinal bleeding or uncontrolled peptic ulcer disease
  • No prior inflammatory bowel disease
  • No other prior or concurrent malignancy except squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or malignancy in complete remission for at least 1 year from the time a response was first documented
  • No severe or life-threatening infection within the past 2 weeks
  • No abnormality that would be scored as grade 3 toxicity except lymphopenia or direct manifestations of KS
  • No known hypersensitivity to interleukin-12 (IL-12) or other compounds known to cross-react with IL-12
  • No other medical condition that would preclude study entry


Biologic therapy:

  • More than 2 weeks since prior cytokines or colony-stimulating factors other than epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
  • No prior combination interleukin-12 and doxorubicin HCl liposome except for patients previously treated on this protocol who are being enrolled for paclitaxel salvage therapy
  • No concurrent immunomodulatory agents
  • No concurrent cytokines except epoetin alfa or G-CSF


  • See Disease Characteristics
  • See Biologic therapy
  • At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • More 6 months since prior suramin
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • More than 2 months since prior systemic glucocorticoid steroids at doses sufficient to affect immune response (e.g., more than 20 mg of prednisone for more than 1 week)
  • Concurrent replacement glucocorticoid therapy allowed
  • No other concurrent systemic glucocorticoid therapy


  • Not specified


  • Not specified


  • Concurrent antiretroviral therapy required
  • No other concurrent anti-KS therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020449

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Pallavi P. Kumar, MD NCI - HIV and AIDS Malignancy Branch

Publications of Results:
Little RF, Aleman K, Merced K, et al.: Preliminary results of combination liposomal doxorubicin and interleukin-12 followed by chronic IL-12 maintenance therapy in advanced AIDS-related Kaposi's sarcoma. [Abstract] 10th Conference on Retroviruses and Opportunistic Infections, February 10-14, 2003, Boston, Massachusetts A-816, 2003. Identifier: NCT00020449     History of Changes
Obsolete Identifiers: NCT00008879
Other Study ID Numbers: CDR0000068502
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: March 2004

Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma

Additional relevant MeSH terms:
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors