Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

March 17, 2022 updated by: Weill Medical College of Cornell University

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

Completed

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

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Biological: recombinant interferon alfa
Drug: tretinoin liposome

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

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Study Chair: David M. Nanus, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1999

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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