EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma

Study Overview
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Brief Summary
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Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposi's sarcoma. EMD 121974 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

Detailed Description
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OBJECTIVES: I. Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposi's sarcoma. 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.

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

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: cilengitide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven Kaposi's sarcoma Systemic chemotherapy not required Minimum of 2 lesions amenable to biopsy Measurable or evaluable disease HIV positive PATIENT CHARACTERISTICS: 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 (ULN)) 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 PRIOR CONCURRENT THERAPY: 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 illness Antiretroviral therapy must be stable for 4 weeks prior to study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: cilengitide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma