Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226798
Status:
UNKNOWN
Last Update Posted:
2006-01-04
First Post:
2005-09-26
Brief Title:
Immunochemotherapy for Metastatic Renal Cell Carcinoma
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Interleukin-2 Interferon AlphaCapecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma A Multicenter Study
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2500mgm2d 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
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 2500mgm2d 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
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 SC 10X106 IUm2 three times a week Sun Tue Thu weeks 1 - 4 Roferon A SC 6 X 106 IUm2 once a week Wed weeks 1 - 4 Roferon A SC 3 X 106 IUm2 three times a week weeks 5 - 8 Xeloda Oral 1000 mgm2 twice a day weeks 5 6 Vinblastine IV 4mgm2 Day 1 weeks 5
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 SC 10X106 IUm2 three times a week Sun Tue Thu weeks 1 - 4 Roferon A SC 6 X 106 IUm2 once a week Wed weeks 1 - 4 Roferon A SC 3 X 106 IUm2 three times a week weeks 5 - 8 Xeloda Oral 1000 mgm2 twice a day weeks 5 6 Vinblastine IV 4mgm2 Day 1 weeks 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Raphael Rubinov | None | None | None |