- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226798
Immunochemotherapy for Metastatic Renal Cell Carcinoma
Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a phase II study, non-randomized in patients with metastatic renal cell carcinoma. The treatment will include: Proleukin (produced by Chiron and supplied by Megapharm Israel Ltd), Roferon A and Xeloda (produced by Roche) and VBL. The treatment will be given in 8-week courses with an interval of two weeks of rest in which the response (on D63) and toxicity will be assessed.
45 patients with MRCC will be entered into this study during a 18-month period. All patients must meet all inclusion and exclusion criteria. All data of each participating patient, including medical history, disease characteristics, laboratory and imaging tests, response and toxicity to treatment will be entered into the specific form before, during, after each treatment course and during follow up.
Patients will be followed up for survival status and disease status every 6 months until last visit or death.
Treatment Schedule:
Proleukin S.C. 10X106 IU/m2 three times a week (Sun, Tue, Thu), weeks 1 - 4 Roferon A S.C. 6 X 106 IU/m2 once a week (Wed), weeks 1 - 4 Roferon A S.C. 3 X 106 IU/m2 three times a week, weeks 5 - 8 Xeloda Oral 1,000 mg/m2 twice a day, weeks 5, 6 Vinblastine I.V. 4mg/m2, Day 1, weeks 5 &
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Eliahu Gez, MD
- Phone Number: 972-4-8542012
- Email: e_gez@rambam.health.gov.il
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Rambam Medical Center
-
Contact:
- Eliahu Gez, MD
- Phone Number: 972-4-8542012
- Email: e_gez@rambam.health.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Objective response
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Eliahu Gez, MD, Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Adenocarcinoma, Clear Cell
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- 1747CTIL
- Raphael Rubinov
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenocarcinoma Clear Cell
-
M.D. Anderson Cancer CenterRecruitingHuman Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-TypeUnited States
-
National University Hospital, SingaporeUnknownOvarian Clear Cell CarcinomaSingapore
-
University Health Network, TorontoCompleted
-
M.D. Anderson Cancer CenterGSK Pharma; LixteRecruitingOvarian Clear Cell CarcinomaUnited States
-
Peking University Third HospitalNot yet recruitingOvarian Clear Cell Carcinoma
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Endometrial AdenocarcinomaUnited States
-
Tongji HospitalWuhan University; Henan Cancer Hospital; Qilu Hospital of Shandong University; Hubei... and other collaboratorsRecruitingOvarian Clear Cell CarcinomaChina
-
M.D. Anderson Cancer CenterActive, not recruitingRecurrent Platinum-Resistant Ovarian Carcinoma | Recurrent Fallopian Tube Clear Cell Adenocarcinoma | Recurrent Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Fallopian Tube Carcinoma | Recurrent Platinum-Resistant Primary Peritoneal Carcinoma | Recurrent Primary Peritoneal...United States
-
National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Clear Cell AdenocarcinomaUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Uterine Corpus Carcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Adenocarcinoma | Endometrial Adenosquamous CarcinomaUnited States
Clinical Trials on Capecitabine (Xeloda)
-
Hoffmann-La RocheCompletedColorectal CancerSlovakia
-
University of AarhusPierre Fabre LaboratoriesCompleted
-
Hoffmann-La RocheCompletedBreast Cancer, Colorectal CancerNew Zealand, Australia, United Kingdom
-
Asan Medical CenterUlsan University Hospital; Seoul National University Bundang Hospital; Gachon... and other collaboratorsRecruitingGastric CancerKorea, Republic of
-
Hoffmann-La RocheTerminated
-
Hoffmann-La RocheCompleted
-
Cambridge University Hospitals NHS Foundation TrustCompletedPancreatic AdenocarcinomaUnited Kingdom
-
Hoffmann-La RocheCompleted
-
Sun Yat-sen UniversityRecruiting
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)Completed