Know Cancer

forgot password

A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

OBJECTIVES: I. Evaluate the safety and tolerability of SU5416 in patients with AIDS-related
Kaposi's sarcoma. II. Determine the pharmacokinetics of this regimen in these patients. III.
Evaluate the antitumor effects and biological activity of this regimen in these patients.
IV. Determine the safety of this regimen on HIV replication and immune parameters in these

OUTLINE: This is a dose escalation, multicenter study. Patients receive SU5416 by
intravenous injection twice weekly for 4 weeks. Patients may continue treatment for a
maximum of 1 year in the absence of disease progression and unacceptable toxicity. In the
absence of dose limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts
of 6 patients each receive escalating doses of SU5416 on the same schedule. If DLT occurs in
2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose
is declared the maximum tolerated dose (MTD). Six additional patients are treated at the
MTD. Patients are followed at 30 days after the last treatment, and every 3 months

PROJECTED ACCRUAL: This study will accrue a maximum of 30 patients.

Inclusion Criteria

DISEASE CHARACTERISTICS: Biopsy proven Kaposi's sarcoma that is stable or progressing
while receiving standard therapy HIV positive No severe pulmonary Kaposi's sarcoma Five
measurable lesions of at least 10 mm or lesions present for at least 30 days OR KS-related
generalized edema or edema of the extremities without evidence of active mucocutaneous

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 750/mm3
without transfusion Hemoglobin at least 8.0 g/dL without transfusion Platelet count at
least 50,000/mm3 without transfusion Hepatic: AST/ALT no greater than 2.5 times upper
limit of normal (ULN) Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL if concurrent
indinavir therapy) Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at
least 50 mL/min Other: Not pregnant Fertile patients must use effective contraception No
known allergy to Cremophor or Cremophor based drug product No concurrent uncontrolled
serious infection such as: Pneumocystis carinii pneumonia Toxoplasma brain abscess CMV
retinitis or colitis Cryptococcal meningitis Symptomatic Mycobacterium
avium-intracellulare No other active malignancy except: Basal cell carcinoma of the skin
Carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy
for AIDS-related Kaposi's sarcoma At least 2 weeks since prior immunotherapy for
AIDS-related Kaposi's sarcoma and recovered At least 2 weeks since prior epoetin alfa,
filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent immunotherapy Chemotherapy: At
least 2 weeks since prior chemotherapy for AIDS-related Kaposi's sarcoma and recovered No
concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy
for AIDS-related Kaposi's sarcoma No concurrent hormonal therapy (including beta-HCG)
Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At
least 4 weeks since prior surgery and recovered No prior biopsy of measurable lesion
Other: No prior laser therapy to measurable lesion Stable antiretroviral therapy for at
least 2 weeks At least 3 weeks since other investigational drugs No concurrent local or
topical therapy for disease No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Alison L. Hannah, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

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



Kaplan Cancer Center New York, New York  10016
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
St. Francis Hospital San Francisco, California  94109