Clinical trial · Interventional
A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
NCT00002262CI-TRIAL-00000042completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Sarcoma, Kaposi | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor Necrosis Factor | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria Patients must have: * Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions. * Minimum life expectancy of 3 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Clinically significant cardiac disease. * Known hemorrhagic diathesis or active bleeding disorder. * Clinically apparent vascular disease. * Known lipoprotein disorders. * History of seizure disorder or central nervous system (CNS) metastasis. * Additional malignancy. Concurrent Medication: Excluded: * Cardiac agents. * Anticoagulants. * Thrombolytic agents. * Nonsteroidal anti-inflammatory drugs. * Corticosteroids. * Aspirin. * Vasodilators. Patients with the following are excluded: * Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions. Prior Treatment: Excluded within 4 weeks of study entry: * Chemotherapy. * Radiotherapy. * Immunotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.