Immunochemotherapy for Metastatic Renal Cell Carcinoma

NCT00226798 | Unknown Phase 2

• 2 other identifiers: 1747CTILRaphael Rubinov
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Adenocarcinoma Clear Cell

Outcome Measures

Primary Outcomes (1)

• Objective response

Secondary Outcomes (1)

• Toxicity

Interventions

Capecitabine (Xeloda) DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Rambam medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma, Clear Cell

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Eliahu Gez, MD

  Rambam Health Care Campus

  STUDY CHAIR

Central Study Contacts

Eliahu Gez, MD

CONTACT

972-4-8542012; e_gez@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 27, 2005
• Study Start: December 1, 2003
• Study Completion: September 1, 2005
• Last Updated: January 4, 2006

Record last verified: 2005-09

Locations

IL (1)