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

National Cancer Institute (NCI)

Status and phase

Terminated

Phase 1

Conditions

Sarcoma

Treatments

Drug: cilengitide

Study type

Interventional

Funder types

NIH

Identifiers

NCT00006222

NCI-2012-02358

CDR0000068142 (Registry Identifier)

AMC-023

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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