Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003656
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: May 2006
  Purpose

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 Intervention Phase
Kidney Cancer
Biological: recombinant interferon alfa
Drug: tretinoin liposome
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response as measured by CT, bone scans, and clinical progression at 8 weeks after first dose [ Designated as safety issue: No ]
  • Toxicity by clinical evaluation from first dose to 30 days after last dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Retinoic acid receptor expression on tissue as measured by the presence of peripheral blood lymphocytes during the first and fifth dose [ Designated as safety issue: 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 [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: January 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003656

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Study Chair: David M. Nanus, MD Weill Medical College of Cornell University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003656     History of Changes
Other Study ID Numbers: CDR0000066748, NYWCCC-0498-209, NCI-V98-1490
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferons
Tretinoin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 28, 2014