Expired Study
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Bethesda, Maryland 20892


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.

Study summary:

OBJECTIVES: - 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.


DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 30-100% Life expectancy: - More than 2 months Hematopoietic: - Hemoglobin at least 9.0 g/dL - Absolute neutrophil count at least 750/mm^3 - Platelet count at least 75,000/mm^3 Hepatic: - 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 Renal: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min Cardiovascular: - No congestive heart failure - Ejection fraction at least 40% by MUGA or echocardiogram Other: - 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 PRIOR CONCURRENT THERAPY: 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 Chemotherapy: - 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 Radiotherapy: - Not specified Surgery: - Not specified Other: - Concurrent antiretroviral therapy required - No other concurrent anti-KS therapy



Primary Contact:

Study Chair
Pallavi P. Kumar, MD
NCI - HIV and AIDS Malignancy Branch

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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