Clinical trial · Interventional
EMD 121974 in Treating Patients With HIV-Related Kaposi's Sarcoma
A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposi's Sarcoma
NCT00006222CI-TRIAL-00010524terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cilengitide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Drug: cilengitide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.