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Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy


Phase 2
12 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy


Etoposide may be at least as, or even more, effective and less myelotoxic when given in low
doses over prolonged periods of time.

Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients
who achieve a complete or partial response after two cycles and have no toxicity greater
than grade 2 may have their dose escalated for subsequent cycles. If there are no responses
to therapy among the first 14 evaluable patients, the study will close; if there is at least
one objective response to therapy among the first 14 evaluable patients, enrollment will
continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor
response (either stable disease or complete response) is achieved or disease progression
occurs.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Maintenance therapy for opportunistic infections.

Patients must have:

- HIV infection.

- Kaposi's sarcoma that has relapsed or progressed.

- Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral
Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these
three conditions).

- NO active acute opportunistic infections requiring treatment with myelosuppressive
antibiotics (maintenance for OIs is permitted).

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

NOTE:

- This study is approved for prisoner participation.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Other active malignancies except basal cell carcinoma of the skin, or carcinoma in
situ of the cervix.

- Grade 3 or worse peripheral neuropathy.

- Altered mental status that would prevent informed consent or prevent study
compliance.

Patients with the following prior condition are excluded:

Neuropsychiatric history.

Prior Medication:

Excluded:

- Prior etoposide.

- Any other anti-KS drugs within 14 days prior to study entry.

- Any investigational drug other than antiretrovirals within 14 days prior to study
entry.

- Any prior investigational agent, if given as the ONLY prior treatment for KS.

Prior Treatment:

Excluded:

- Radiation therapy within 7 days prior to study entry.

Continued alcohol consumption or continued intravenous drug use that would impair ability
to comply with study requirements.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Von Roenn JH

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 269

NCT ID:

NCT00000807

Start Date:

Completion Date:

July 2000

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Sarcoma, Kaposi
  • Etoposide
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Julio ArroyoWest Columbia, South Carolina  29169
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Univ of Miami School of MedicineMiami, Florida  331361013
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
Boston Med CtrBoston, Massachusetts  02118
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
City Hosp Ctr at Elmhurst / Mount Sinai HospElmhurst, New York  11373
Mount Sinai Med CtrNew York, New York  10029
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Saint Clare's Hosp and Health CtrNew York, New York  10019
Denver Dept of Health and HospsDenver, Colorado  80262
Yale Univ / New HavenNew Haven, Connecticut  065102483
Adirondack Med Ctr at Saranac LakeAlbany, New York  122083479
Albany Med College / Division of HIV Medicine A158Albany, New York  122083479
Mid - Hudson Care CtrAlbany, New York  122083479
Columbia Presbyterian Med CtrNew York, New York  100323784
K Norris Cancer Hosp / Los Angeles County - USC Med CtrLos Angeles, California  900331079