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

May 31, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: cilengitide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Barbara J. Klencke, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

March 1, 2001

Study Completion (Actual)

March 1, 2001

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

May 25, 2004

First Posted (Estimate)

May 26, 2004

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

April 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02358
  • AMC-023
  • CDR0000068142 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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