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

NCT ID: NCT00006222

Last Updated: 2013-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2001-03-31

Brief Summary

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

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.

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

cilengitide

Intervention Type: DRUG

Interventions

cilengitide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J. Klencke, MD

Role: STUDY_CHAIR

University of California, San Francisco

Locations

University of California San Diego Cancer Center

La Jolla, California, United States

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Vanderbilt Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

AMC-023

Identifier Type: -

Identifier Source: secondary_id

CDR0000068142

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02358

Identifier Type: -

Identifier Source: org_study_id