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A Phase II Study of Liposomal Doxorubicin and Interleukin-12 in AIDS-Associated Kaposi's Sarcoma Followed by Chronic Administration of Interleukin-12

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study of Liposomal Doxorubicin and Interleukin-12 in AIDS-Associated Kaposi's Sarcoma Followed by Chronic Administration of Interleukin-12


- 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

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Pallavi P. Kumar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - HIV and AIDS Malignancy Branch


United States: Federal Government

Study ID:




Start Date:

January 2001

Completion Date:

May 2004

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182