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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00003656
Date of registration: 01/11/1999
Primary sponsor: Weill Medical College of Cornell University
Public title: Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Scientific title: Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
Date of first enrolment: January 1999
Target sample size: 43
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Name:   David M. Nanus, MD
Affiliation:  Weill Medical College of Cornell University
Key inclusion & exclusion criteria


- Histologically confirmed metastatic renal cell carcinoma

- Bidimensionally measurable disease

- No active brain metastases



- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 3 months


- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- No coagulation disorders


- Bilirubin less than 1.5 mg/dL

- SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal

- No clinically significant hepatic disease, including autoimmune hepatitis


- Creatinine less than 2 mg/dL OR

- Creatinine clearance greater than 50 mL/min

- No clinically significant renal disease


- No clinically significant cardiac disease

- No thrombophlebitis


- No severe debilitating pulmonary disease

- No pulmonary embolism


- No history of diabetes mellitus prone to ketoacidosis

- No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon
or any component of the injection for this study

- No thyroid abnormalities that hinder maintaining thyroid function at the normal range

- No severe infection

- No severe malnutrition

- No clinically significant retinal abnormalities

- No pre-existing psychiatric condition, especially depression or a history of severe
psychiatric disorder

- No other concurrent malignancy except nonmelanoma skin cancer or curatively treated
carcinoma in situ of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception during and for 1 month
after study participation


Biologic therapy:

- No more than 1 prior biological response modifier therapy or immunotherapy


- No more than 1 prior chemotherapy regimen

Endocrine therapy:

- No concurrent steroids


- At least 4 weeks since prior radiotherapy


- At least 4 weeks since prior major surgery


- No prior retinoid therapy

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Kidney Cancer
Biological: recombinant interferon alfa
Drug: tretinoin liposome
Primary Outcome(s)
Response as measured by CT, bone scans, and clinical progression at 8 weeks after first dose [Time Frame: No]
Toxicity by clinical evaluation from first dose to 30 days after last dose [Time Frame: Yes]
Secondary Outcome(s)
Retinoic acid receptor expression on tissue as measured by the presence of peripheral blood lymphocytes during the first and fifth dose [Time Frame: No]
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: No]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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