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Phase I/II Pilot Study of Interleukin-12 in Patients With AIDS-Associated Kaposi's Sarcoma

Phase 1/Phase 2
18 Years
Not Enrolling
Epidemic Kaposi's Sarcoma, Recurrent Kaposi's Sarcoma

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Trial Information

Phase I/II Pilot Study of Interleukin-12 in Patients With AIDS-Associated Kaposi's Sarcoma

OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-12 (IL-12) in patients
with AIDS-associated Kaposi's sarcoma.

II. Determine the antitumor activity of IL-12 in these patients. III. Determine the effect
of IL-12 on angiogenic factors, including basic fibroblast growth factor, vascular
endothelial growth factor, and interferon-inducible protein 10 in these patients.

IV. Determine the immunologic and virologic effects of IL-12 in these patients.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive interleukin-12 (IL-12)
subcutaneously twice a week (at least 3 days apart) for 6 months. Patients with stable or
better disease continue IL-12 treatment in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of IL-12 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity. Ten additional patients are treated at the MTD.

Patients are followed at 4 weeks.


Up to 55 patients will be entered over approximately 4.0 years.

Inclusion Criteria


--Disease Characteristics-- Histologically proven Kaposi's sarcoma (KS) At least 5 lesions
evaluable by noninvasive methods No acutely life threatening lesions that may be
responsive to other therapy Actively bleeding or critically located lesions may be
excluded at the discretion of the Study Chair or Principal Investigator Asymptomatic
pulmonary disease not requiring immediate cytotoxic therapy allowed HIV-associated disease
Anti-HIV serum antibodies measured by ELISA and Western blot Stable dose of two or more of
the following antiretroviral agents required for 4 weeks prior to study: Lamivudine
Didanosine Zidovudine Saquinavir Stavudine Ritonavir Zalcitabine Indinavir
Nonnucleoside reverse transcriptase inhibitor Other protease inhibitor Antiretroviral
therapy unchanged during study unless medically warranted Patients may switch between
antiretroviral agents provided they continue to receive a combination of 2 or more agents
--Prior/Concurrent Therapy-- Biologic therapy: At least 6 months since prior
interleukin-12 (IL-12) At least 3 weeks since prior interferon therapy At least 2 weeks
since prior cytokines or bone marrow stimulating factors (except epoetin alfa) No
concurrent cytokines except epoetin alfa or filgrastim (G-CSF) Chemotherapy: At least 3
weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas or mitomycin) At
least 6 months since prior suramin Endocrine therapy: Replacement glucocorticoids allowed
At least 2 months since prior systemic glucocorticoids at doses sufficient to affect
immune response (e.g., more than 20 mg of prednisone or equivalent for more than 1 week)
Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: See
Disease Characteristics At least 3 weeks since prior anti-KS therapy At least 3 weeks
since prior local therapy (e.g., intralesional injections) --Patient Characteristics--
Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 3
months Hematopoietic: Absolute neutrophil count at least 750/mm3 Platelet count at least
75,000/mm3 Hemoglobin at least 9.0 g/dL (no transfusion within 1 month prior to entry)
Hepatic: Bilirubin no greater than 3.7 mg/dL with direct fraction no greater than 0.2
mg/dL and indirect fraction no greater than 3.5 mg/dL AST no greater than 2.5 times upper
limit of normal No history of cirrhosis PT/PTT no greater than 120% of control Renal:
Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: No
hypersensitivity to IL-12 or other compounds that crossreact with IL-12 No clinically
significant autoimmune disease (e.g., systemic lupus erythematosus) or rheumatologic
disease No active, gross gastrointestinal bleeding or uncontrolled peptic ulcer disease No
inflammatory bowel disease No severe or life threatening infection with bacterial, viral,
fungal, protozoal, or parasitic pathogens within 2 weeks of entry No fever of 39 degrees
Celsius or higher within 10 days prior to entry unless underlying infection ruled out No
second malignancy within 1 year except: Completely resected basal cell carcinoma Carcinoma
in situ of the cervix No generalized debilitation or mental incapacitation that would
preclude informed consent No abnormality that would score as a grade 3 toxicity other than
lymphopenia or direct manifestations of KS Willing to refrain from unprotected sexual
contact and other activities that could result in reinfection with HIV Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception during
and for 2 months after study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Yarchoan

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

January 1997

Completion Date:

March 2007

Related Keywords:

  • Epidemic Kaposi's Sarcoma
  • Recurrent Kaposi's Sarcoma
  • AIDS-related malignancies
  • Kaposi's sarcoma
  • adult solid tumor
  • body system/site cancer
  • cancer
  • epidemic Kaposi's sarcoma
  • recurrent Kaposi's sarcoma
  • skin tumor
  • solid tumor
  • stage, Kaposi's sarcoma
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



Medicine Branch Bethesda, Maryland  20892