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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Interleukin-12; Liposomal doxorubicin; Paclitaxel

Criteria

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