NCT00006222

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2000

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

May 26, 2004

Completed
Last Updated

June 3, 2013

Status Verified

April 1, 2001

Enrollment Period

6 months

First QC Date

September 11, 2000

Last Update Submit

May 31, 2013

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcomarecurrent Kaposi sarcoma

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

cilengitideDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

SarcomaAIDS-related Kaposi sarcomaSarcoma, Kaposi

Interventions

Cilengitide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular Tissue

Study Officials

  • Barbara J. Klencke, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

May 26, 2004

Study Start

September 1, 2000

Primary Completion

March 1, 2001

Study Completion

March 1, 2001

Last Updated

June 3, 2013

Record last verified: 2001-04

Locations

US(3)