NCT00000769

Brief Summary

To determine the safety and tolerance of interleukin-4 (IL-4) in patients with AIDS-related Kaposi's sarcoma. To determine the effects of IL-4 on tumor growth in patients with AIDS-related 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

Sarcoma, KaposiHIV Infections

Keywords

Sarcoma, KaposiAcquired Immunodeficiency SyndromeInterleukin-4

Interventions

Interleukin-4DRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Required:
  • Antiretroviral therapy during study treatment only in patients with CD4 count \< 500 cells/mm3 (per 12/30/94 amendment).
  • Allowed:
  • 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 fevers.
  • 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.
  • +4 more criteria

You may not qualify if:

  • 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:
  • Excluded:
  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Miles SA, Mitsuyasu R, LaFleur F, Ryback M, Kasden P, Suckow C, Groopman J, Scadden D. Phase I/II trial of interleukin-4 in KS (ACTG 224). Int Conf AIDS. 1994 Aug 7-12;10(1):46 (abstract no 159B)

    BACKGROUND

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Interleukin-4

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Miles S

    STUDY CHAIR

  • Scadden D

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

April 1, 1998

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

US(3)