Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

• Register: ClinicalTrials.gov
• 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
• URL: http://clinicaltrials.gov/show/NCT00003656
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David M. Nanus, MD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic renal cell carcinoma

- Bidimensionally measurable disease

- No active brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

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

- No coagulation disorders

Hepatic:

- 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

Renal:

- Creatinine less than 2 mg/dL OR

- Creatinine clearance greater than 50 mL/min

- No clinically significant renal disease

Cardiovascular:

- No clinically significant cardiac disease

- No thrombophlebitis

Pulmonary:

- No severe debilitating pulmonary disease

- No pulmonary embolism

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

- No more than 1 prior chemotherapy regimen

Endocrine therapy:

- No concurrent steroids

Radiotherapy:

- At least 4 weeks since prior radiotherapy

Surgery:

- At least 4 weeks since prior major surgery

Other:

- No prior retinoid therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Cancer

Intervention(s)

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)

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]

Retinoic acid receptor expression on tissue as measured by the presence of peripheral blood lymphocytes during the first and fifth dose [Time Frame: No]

Secondary ID(s)

CDR0000066748

NCI-V98-1490

NYWCCC-0498-209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors