Clinical trial NCT00000807: Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
Official title: Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Sarcoma, Kaposi
Etoposide
Acquired Immunodeficiency Syndrome
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Bristol-Myers Squibb
First posted: 2001-08-31
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose etoposide administered for 7 consecutive days every other week in patients with AIDS-related Kaposi's sarcoma that has relapsed or progressed 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
state: California
city: Los Angeles
country: United States
facility: Univ of Southern California / LA County USC Med Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: Denver
country: United States
facility: Denver Dept of Health and Hosps
state: Colorado
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: New Haven
country: United States
facility: Yale Univ / New Haven
state: Connecticut
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Boston
country: United States
facility: Boston Med Ctr
state: Massachusetts
city: Albany
country: United States
facility: Adirondack Med Ctr at Saranac Lake
state: New York
city: Albany
country: United States
facility: Albany Med College / Division of HIV Medicine A158
state: New York
city: Albany
country: United States
facility: Mid - Hudson Care Ctr
state: New York
city: Buffalo
country: United States
facility: SUNY / Erie County Med Ctr at Buffalo
state: New York
city: Elmhurst
country: United States
facility: City Hosp Ctr at Elmhurst / Mount Sinai Hosp
state: New York
city: New York
country: United States
facility: Saint Clare's Hosp and Health Ctr
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: West Columbia
country: United States
facility: Julio Arroyo
state: South Carolina
Study officials:
name: Von Roenn JH
role: STUDY_CHAIR
name: Paredes J
role: STUDY_CHAIR
References:
citation: Mans D, Sprinz E, Sander I, Kalakun F, Jung G, Prolla G, Schwartsmann G. A phase II study of oral etoposide (VP-16) in AIDS-related Kaposi's sarcoma (KS). Int Conf AIDS. 1994 Aug 7-12;10(1):173 (abstract no PB0118)
citation: Evans SR, Krown SE, Testa MA, Cooley TP, Von Roenn JH. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol. 2002 Aug 1;20(15):3236-41. doi: 10.1200/JCO.2002.12.038.