Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00003656|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 8, 2017
RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Biological: recombinant interferon alfa Drug: tretinoin liposome||Phase 2|
- Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b.
- Determine the toxicity of this regimen in these patients.
- Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies.
OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.)
Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.)
During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.)
Patients are followed at 30 days after the last treatment.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma|
|Actual Study Start Date :||January 1999|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Experimental: All subjects
Weekly ATRA-IV with recombinant interferon alfa
|Biological: recombinant interferon alfa Drug: tretinoin liposome|
- Response as measured by CT, bone scans, and clinical progression at 8 weeks after first dose [ Time Frame: 8 weeks after first dose ]
- Toxicity by clinical evaluation from first dose to 30 days after last dose [ Time Frame: from first dose to 30 days after last dose ]
- Retinoic acid receptor expression on tissue as measured by the presence of peripheral blood lymphocytes during the first and fifth dose [ Time Frame: during the first and fifth dose ]
- Duration of response (progression-free survival) as measured by CT, bone scans, and clinical progression from initiation of therapy until an increase of ≥ 25% from the smallest sum of all tumor measurements obtained during the best response [ Time Frame: rom initiation of therapy until an increase of ≥ 25% from the smallest sum of all tumor measurements obtained during the best response ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003656
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|Study Chair:||David M. Nanus, MD||Weill Medical College of Cornell University|