Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Aminocamptothecin in Treating Patients With AIDS-Related Kaposi's Sarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	E-2D94 AMC-006, E2D94

Objectives

I.  Estimate the overall and complete response rates to a dimethylacetamide 
formulation of aminocamptothecin (9-AC) administered intravenously in patients 
with symptomatic AIDS-related Kaposi's sarcoma.

II.  Describe the toxicities of this treatment.

III.  Evaluate the effects of 9-AC on HIV disease status in these patients by 
monitoring CD4 and CD8 lymphocyte counts, quantitative plasma HIV RNA (by 
polymerase chain reaction), and the incidence and types of opportunistic 
infections.

IV.  Correlate the response to 9-AC with quality of life as measured by the 
Functional Assessment of HIV Infection.

Entry Criteria

Disease Characteristics:

Biopsy-proven, symptomatic Kaposi's sarcoma (KS) with one of the following:
  Untreated skin lesions associated with symptomatic edema
  Symptomatic oropharyngeal or conjunctival lesions
  Visceral involvement

Documented progressive disease if there was prior treatment

No acute, life-threatening KS for which other therapies are available

Measurable disease required
  No prior irradiation to indicator lesion

Serologically diagnosed HIV infection by a positive ELISA and confirmed by
Western blot or other diagnostic HIV test

Prior/Concurrent Therapy:

At least 2 weeks since other investigational drugs

Biologic therapy:
  At least 2 weeks since biologic response modifier therapy (BRMT), including
  G-CSF and GM-CSF
     Documented progression following BRMT

Chemotherapy:
  No more than 3 prior systemic cytotoxic chemotherapy
  At least 2 weeks since chemotherapy
     Documented progression following chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 1 week since radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Hematopoietic:
  ANC at least 1,000/mm3
  Platelet count at least 75,000/mm3

Hepatic:
  Bilirubin no more than 1.5 x normal
  SGOT no more than 2.5 x normal
  Alkaline phosphatase no more than 2.5 x normal

Renal:
  Creatinine no more than 1.5 mg/dL OR
  Creatinine clearance at least 60 mL/min

Other:
  No untreated active infection
     At least 2 weeks since any new infectious complication requiring change
        of antibiotics
     Evaluation of the following symptoms strongly recommended:
        Unexplained fevers
        Night sweats
        Involuntary weight loss of more than 10% of normal weight
        Diarrhea of more than 2 weeks duration
  No prior or concurrent malignancy except curatively treated:
     Cervical carcinoma in situ
     Nonmelanomatous skin cancer
  No neuropsychiatric history or altered mental status that may preclude
     compliance
  No pregnant or nursing women
  Effective contraception required of fertile patients

Blood/body fluid analyses and imaging/exams for measurable or evaluable
  disease within 14 days prior to registration
Other screening exams within 42 days prior to registration

Expected Enrollment

Up to 44 patients will be entered to obtain 40 evaluable patients over 12-15 
months.  If there are fewer than 4 responses in the first 18 evaluable 
patients, accrual will cease.

Outline

Single-Agent Chemotherapy.  Aminocamptothecin (dimethylacetamide formulation), 
9-AC, NSC-603071.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

David Henry, MD, Protocol chair(Contact information may not be current)		Ph: 215-829-6088; 800-789-7366