Clinical trial · Interventional
Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
NCT00082914CI-TRIAL-00010895completedPhase 2ClinicalTrials.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)
RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| denileukin diftitox | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical response
Secondary outcomes (2)
- measure
- Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Melanoma * Kidney cancer * Metastatic disease * Measurable disease * Documented disease progression while receiving standard therapy * No resectable local or regional disease PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 90,000/mm\^3 * Lymphocyte count ≥ 500/mm\^3 * No concurrent coagulation disorders Hepatic * Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL for patients with Gilbert's syndrome) * AST and ALT \< 3 times normal * Albumin ≥ 2.5 g/dL * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * Normal thallium stress test\* * No prior myocardial infarction * No history of severe coronary artery disease * No major medical illness of the cardiovascular system NOTE: \*For patients \> 50 years of age OR who have a history of cardiovascular disease Pulmonary * No major medical illness of the respiratory system Immunologic * HIV negative * No active systemic infection * No presence of opportunistic infections * No primary or secondary immunodeficiency * No autoimmune disease * No other known immunodeficiency Other * No sensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or excipients) * Willing to undergo leukapheresis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Prior treatment with interleukin-2 allowed provided the patient's disease status required this therapy Chemotherapy * Recovered from prior chemotherapy Endocrine therapy * No concurrent systemic steroids Radiotherapy * Recovered from prior radiotherapy Surgery * Not specified Other * More than 3 weeks since prior systemic anticancer therapy * No other concurrent systemic anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.