EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma
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ClinicalTrials.gov Identifier: NCT00006222 |
Recruitment Status
:
Terminated
(Administratively complete.)
First Posted
: May 26, 2004
Last Update Posted
: June 3, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Drug: cilengitide | Phase 1 |
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 (Clinical Trial) |
Actual Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma |
Study Start Date : | September 2000 |
Actual Primary Completion Date : | March 2001 |
Actual Study Completion Date : | March 2001 |
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 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006222
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 |
Study Chair: | Barbara J. Klencke, MD | University of California, San Francisco |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006222 History of Changes |
Other Study ID Numbers: |
NCI-2012-02358 AMC-023 CDR0000068142 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | May 26, 2004 Key Record Dates |
Last Update Posted: | June 3, 2013 |
Last Verified: | April 2001 |
Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Additional relevant MeSH terms:
Sarcoma Sarcoma, Kaposi Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Herpesviridae Infections DNA Virus Infections Virus Diseases Neoplasms, Vascular Tissue |