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

Primary Purpose

Sarcoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cilengitide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego Cancer Center
  • UCSF Cancer Center and Cancer Research Institute
  • Vanderbilt Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
May 31, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006222
Brief Title
EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma
Official Title
A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2001
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
September 2000 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
March 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cilengitide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Klencke, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-0128
Country
United States
Facility Name
Vanderbilt Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

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

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