Clinical trial · Interventional
Immunochemotherapy for Metastatic Renal Cell Carcinoma
Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study
- 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)
Immunochemotherapy consisting of IL-2, INF-A, and VBL and 5FU is regarded as the treatment of choice in metastatic renal cell carcinoma. During the period 1996-2000, we evaluated the efficacy and toxicity of this immunochemotherapy, combined with an aggressive surgical approach: nephrectomy before treatment and resection of residual disease. The 3-year survival rate for the entire group and complete responder patients was 30% and 88%, respectively. The side effects were usually moderate and consisted mainly of a flu-like syndrome, headache, nausea, vomiting and depression. Most importantly, there was no drug-related death. Good performance status, absence of bone metastases and prior nephrectomy were associated with higher response rates. Capecitabine is a novel fluoropyrimidine carbamate, orally administered and selectively activated to Fluorouracil by a sequential triple-enzyme pathway in liver and tumor cells. Capecitabine at dose of 2,500mg/m2/d divided equally into two daily doses for 14 days in patients who failed to respond to "standard" immunotherapy achieved a 30% objective response. Toxicity consisted of hand-foot syndrome. Aim of Study: To evaluate efficacy and toxicity of the combination of IL-2, INF-A, VBL and Capecitabine in MRCC
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 |
|---|---|---|---|
| Adenocarcinoma Clear Cell | Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine (Xeloda) | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response
Secondary outcomes (1)
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: \- Inclusion Criteria; Patients with the following criteria will be included in this study * Pathological (histology or cytology) diagnosis of renal cell carcinoma * Clinical evidence of metastatic disease * Performance status 0 - 2 (European Cooperative Oncology Group Score) * Nephrectomy before starting treatment * Normal cardiac function (left ventricular ejection fraction \>45%). * Normal blood counts: WBC \>3,000/ml3, Hb \>10gr%, Platelets \>100,000/ml3 * Normal kidney function: Creatinine \<1.3 mg/dl * Age 18 years * Patient's written consent (on informed consent form) Exclusion Criteria: * Life expectancy less than 3 months * Brain metastases * Ischemic heart disease - active * Prior immunochemotherapy * Performance status 3 or more (European Cooperative Oncology Group Score) * Schizophrenia * Active liver disease
References
Publications (0)
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