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

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Drug: cilengitide	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Classic Kaposi Sarcoma Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):


Enrollment:	30
Study Start Date:	September 2000
Study Completion Date:	March 2001
Primary Completion Date:	March 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006222

Locations


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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


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

More Information

No publications provided


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006222 History of Changes
Other Study ID Numbers:	NCI-2012-02358, AMC-023, CDR0000068142
Study First Received:	September 11, 2000
Last Updated:	May 31, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):


AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma

Additional relevant MeSH terms:


Sarcoma Sarcoma, Kaposi DNA Virus Infections Herpesviridae Infections Neoplasms	Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015