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A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma


OBJECTIVES: I. Determine the antitumor effects of SU5416 in patients with chemotherapy
refractory cutaneous AIDS-related Kaposi's sarcoma. II. Determine the safety and
tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this
regimen in these patients. IV. Determine the safety of this regimen on HIV replication and
immune parameters in these patients. V. Determine the effects of this regimen on overall
quality of life and tumor specific symptoms in these patients.

OUTLINE: This is a multicenter study. Patients receive SU5416 IV twice weekly for 4 weeks.
Treatment continues for up to 1 year in the absence of disease progression or unacceptable
toxicity. Quality of life is assessed. Patients are followed at 30 days after the last
treatment, and every 3 months thereafter.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven, cutaneous AIDS-related Kaposi's sarcoma
(KS) Must have failed at least 1 standard chemotherapy regimen for KS Chemotherapy
refractory (progressed during anthracycline-based or paclitaxel therapy) OR Chemotherapy
intolerant (hypersensitivity to drug or unacceptable toxicity) HIV positive At least 5
measurable cutaneous lesions No prior radiotherapy or intradermal therapy to indicator
lesions OR KS-related generalized edema or edema of the extremities without evidence of
active cutaneous lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life
expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 500/mm3
Platelet count at least 50,000/mm3 Hepatic: AST no greater than 5.0 times upper limit of
normal Bilirubin no greater than 2.0 mg/dL (no greater than 3.0 mg/dL if concurrent
indinavir therapy) Renal: No history of renal failure Creatinine no greater than 1.8 mg/dL
OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within
the past year No severe or unstable angina No history of unstable atherosclerotic coronary
artery disease requiring coronary or peripheral artery bypass surgery within the past 2
years Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No known hypersensitivity to Cremophor or Cremophor based drug
product No uncontrolled serious infection such as: Pneumocystis carinii pneumonia
Toxoplasmic brain abscess CMV retinitis or colitis Cryptococcal meningitis Symptomatic
Mycobacterium avium-intracellulare No other active malignancy, except: Basal cell skin
cancer Carcinoma in situ of the cervix No cerebral bleed No diabetes mellitus with
clinical evidence of severe peripheral vascular disease or diabetic ulcers No other acute
or chronic medical or psychiatric condition that would preclude compliance No history of
metabolic acidosis from nucleoside analogues Anion gap no greater than 11 (Na - Cl, HCO3)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior immunotherapy for
AIDS-related KS and recovered At least 2 weeks since prior biologic therapy for
AIDS-related KS No concurrent immunotherapy Chemotherapy: See Disease Characteristics At
least 2 weeks since prior chemotherapy for AIDS-related KS and recovered No other
concurrent systemic chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal
therapy for AIDS-related KS No concurrent hormonal therapy (including beta-HCG)
Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and
recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery No
prior stereotactic surgery Other: Stable antiretroviral therapy for at least 4 weeks prior
to and at least 29 days during the study Concurrent FDA approved antiretroviral agents or
expanded access antiretroviral agents allowed At least 3 weeks since other prior
investigational agents No concurrent local or topical therapy for AIDS-related KS No other
concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven A. Miles, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UCLA Clinical AIDS Research and Education (CARE) Center

Authority:

United States: Federal Government

Study ID:

CDR0000067633

NCT ID:

NCT00005042

Start Date:

January 2000

Completion Date:

November 2000

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
UCLA Clinical AIDS Research and Education (CARE) CenterLos Angeles, California  90024