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A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma


I. Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposi's

II. Determine the antiangiogenic activity of this drug in these patients. III. Determine the
antitumor activity of this drug in these patients. IV. Determine the effect of this drug on
CD4 and CD8 cell counts and percentages, and on HIV viral load in these patients.

V. Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose escalation study.

Patients receive EMD 121974 IV twice a week for four weeks. Courses repeat every 4 weeks in
the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of EMD
121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
at which no more than 1 of 6 patients experiences dose limiting toxicities.

Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 1 year.

Inclusion Criteria


- Histologically proven Kaposi's sarcoma

- Systemic chemotherapy not required

- Minimum of 2 lesions amenable to biopsy

- Measurable or evaluable disease HIV positive


- Age: 18 and over

- Performance status: Karnofsky 70-100%

- Life expectancy: At least 3 months

- Hemoglobin at least 8.0 g/dL

- Absolute neutrophil count at least 750/mm3

- Platelet count at least 75,000/mm3

- PT/PTT normal Bilirubin normal (bilirubin no greater than 3.5 mg/dL if secondary to
indinavir therapy, provided direct bilirubin no greater than upper limit of normal

- AST (SGOT) no greater than 2.5 times ULN

- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

- No prior ischemic coronary artery disease including prior myocardial infarction

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study

- No concurrent active infection (nonsystemic infection, e.g., herpes simplex, oral
thrush, or warts, allowed)

- No gastric or duodenal ulcer within past 6 weeks unless healed


- At least 2 weeks since prior antineoplastic biologic therapy and recovered

- At least 3 weeks since prior myeloid growth factor

- Growth factors and transfusion allowed if dose requirement is stable for 4 weeks
prior to therapy

- At least 2 weeks since prior chemotherapy (6 weeks since prior nitrosourea or
mitomycin) and recovered

- Concurrent hydroxyurea as antiretroviral therapy allowed if dose stable for 4 weeks
prior to study

- No concurrent systemic cytotoxic chemotherapy

- Recovered from prior endocrine therapy

- At least 2 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

- At least 3 weeks since major surgery or 10 days since minor surgery and recovered

- At least 4 weeks since prior experimental therapy for Kaposi's sarcoma and recovered

- At least 2 weeks since prior local therapy to any indicator lesion

- No concurrent investigational drugs (except antiretroviral therapy)

- At least 2 weeks since prior acute treatment for infection or other serious medical

- Antiretroviral therapy must be stable for 4 weeks prior to study

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Barbara J. Klencke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

September 2000

Completion Date:

March 2001

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma



University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838