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A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma

Phase 1
13 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma

IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor
of Kaposi's sarcoma cells in vitro.

Patients are stratified into two groups according to CD4 count (less than 100 cells/mm3 and
greater than or equal to 100 cells/mm3) and are enrolled in cohorts of four patients at each
of four dose levels of IL-4 per stratum. Within each stratum, if patients at a given dose
level have received at least 2 weeks of study therapy and no more than two patients
experienced grade 3 or 4 drug-related toxicity, dose escalation in subsequent patients may
begin. The MTD is defined as the dose at which 50 percent of patients develop grade 3 or
worse toxicity. Patients with CD4 count less than 500 cells/mm3 (per 12/30/94 amendment)
must be on antiretroviral therapy during study treatment.

PER AMENDMENT 11/20/95: Group I - enrollment is closed, the objective has been defined.
Group II - patients must have CD4 cells greater than or equal to 100/mm3 and less than

PER AMENDMENT 11/20/95: All patients will receive antiretroviral therapy.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- Antiretroviral therapy during study treatment only in patients with CD4 count < 500
cells/mm3 (per 12/30/94 amendment).


- G-CSF for a second occurrence of grade 3 or 4 neutropenia (per 12/30/94 amendment).

- Nonsteroidal anti-inflammatory agents including acetaminophen for drug-related

- Systemic steroids for no more than 1 week in any 30-day period.

- PCP prophylaxis with TMP/SMX, dapsone, or inhaled pentamidine, if patient has a
history of PCP or a CD4 count < 250 cells/mm3.

Allowed only in patients with CD4 count < 100 cells/mm3:

- Maintenance doses of ganciclovir, pyrimethamine/sulfa and TMP/SMX for stable,
well-controlled opportunistic infections.

- Non-myelosuppressive treatment IND medications.

Prior Medication: Required: PER AMENDMENT 11/20/95:

- Stable dose of antiretroviral therapy required for at least 21 days prior to study
entry for all patients. (Changed from - Stable dose of antiretroviral therapy for at
least 21 days prior to study entry in patients with CD4 count < 500 cells/mm3 (per
12/30/94 amendment).

Patients must have:

- AIDS-related Kaposi's sarcoma.

- PER AMENDMENT 11/20/95: CD4 lymphocyte count >= 100 but < 500 cells/mm3. (Changed
from - HIV infection.)

- PER AMENDMENT 11/20/95: All Patients will receive antiretroviral therapy. (Changed
from - Current antiretroviral therapy IF CD4 count < 500 cells/mm3 (per 12/30/94

- No active opportunistic infections requiring induction therapy.

- Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Other active malignancies (except basal cell carcinoma of the skin and in situ
cervical cancer).

- Alteration in mental status that may prevent compliance.

- Cardiac functional capacity of Class II or worse OR regional wall abnormalities or
abnormal ejection fraction on two-dimensional echocardiogram, if performed.

Concurrent Medication:


- Chemotherapy, interferons, or immune modulators for Kaposi's sarcoma.

- Myelosuppressive agents such as induction doses of ganciclovir, Fansidar
(pyrimethamine/sulfadoxine), or any other investigational drugs (with the exception
of non-myelosuppressive treatment IND medications in specific patients).

- GM-CSF or erythropoietin (except for a second grade 3/4 neutropenia or anemia).

- G-CSF.

Patients with the following prior conditions are excluded:

- History of myocardial infarction or significant arrhythmias.

- History of symptomatic hypoglycemia.

Prior Medication:


- Systemic therapy (including chemotherapy, interferons, and immune modulators) for
Kaposi's sarcoma within 4 weeks prior to study entry.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Miles S

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 224



Start Date:

Completion Date:

April 1998

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Interleukin-4
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma



UCLA CARE Center CRS Los Angeles, California  90095
Massachusetts General Hospital ACTG CRS Boston, Massachusetts  02114
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston, Massachusetts  02215