- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003656
Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer
Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All subjects
Weekly ATRA-IV with recombinant interferon alfa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best Response as Measured by CT, Bone Scans, and Clinical Progression
Time Frame: After 8 weeks
|
After 8 weeks
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Time Frame: In 30 days after the last dose, an average of 1 year.
|
In 30 days after the last dose, an average of 1 year.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose
Time Frame: At baseline and 5th week
|
At baseline and 5th week
|
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: At 6 months and 12 months
|
At 6 months and 12 months
|
Collaborators and Investigators
Investigators
- Study Chair: David M. Nanus, MD, Weill Medical College of Cornell University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
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
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Dermatologic Agents
- Keratolytic Agents
- Interferons
- Interferon-alpha
- Tretinoin
Other Study ID Numbers
- 9804003327
- NYWCCC-0498-209
- NCI-V98-1490
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 Kidney Cancer
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnKidney/Urinary Cancer
-
PfizerCompletedKidney Cancer | Kidney Neoplasms | Renal Cell Carcinoma | Renal Cancer | Renal Cell Cancer | Cancer of the Kidney | Cancer of KidneyFinland
-
Tianjin Medical University Second HospitalRecruiting
-
Cedars-Sinai Medical CenterRecruitingProstate Cancer Stage II | Prostate Cancer Stage I | Bladder Cancer Stage II | Kidney Cancer Stage IUnited States
-
Tianjin Medical University Second HospitalRecruiting
-
Dana-Farber Cancer InstituteCompletedKidney Cancer | Prostate Cancer | Genitourinary CancerUnited States
-
Intuitive SurgicalCompleted
-
University of Texas Southwestern Medical CenterCompletedKidney Cancer | Kidney Cancer Metastatic | Kidney Cancer, Stage IVUnited States
-
Yale UniversityCompleted
-
Stanford UniversityNational Cancer Institute (NCI)WithdrawnProstate Cancer | Bladder Cancer | Kidney Tumor
Clinical Trials on recombinant interferon alfa
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBladder Cancer | Urethral CancerUnited States
-
Seoul National University HospitalHanyang UniversityRecruitingCoronary Artery Disease | Stable Angina | Acute Myocardial InfarctionKorea, Republic of
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedBreast Cancer | Metastatic CancerUnited States
-
Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
-
Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
-
Hoffmann-La RocheCompletedRenal Cell Carcinoma | Chronic Myelogenous Leukemia | Malignant MelanomaCanada, India, Bulgaria, Russian Federation, Spain, South Africa, Slovakia
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI); NCIC Clinical Trials Group; Children's Oncology... and other collaboratorsActive, not recruitingMelanoma (Skin)United States, Canada, Australia, South Africa
-
Institute of Cancer Research, United KingdomCompletedMelanoma (Skin)United Kingdom
-
Hackensack Meridian HealthNational Cancer Institute (NCI)WithdrawnMelanoma (Skin)United States