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Tretinoin and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on January 6, 2005.   Last Updated on February 6, 2009   History of Changes
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00100906
  Purpose

RATIONALE: Tretinoin may help cells that are involved in the body's immune response to work better. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving tretinoin together with interleukin-2 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving three different doses of tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Drug: tretinoin
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ratio of dendritic cells (DC) to circulating immature cells (ImC) before and after treatment [ Designated as safety issue: No ]
  • In vitro immune response assays to tetanus toxoid and influenza virus peptide before and after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of treatment-related side effects [ Designated as safety issue: Yes ]
  • Clinical objective response [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Correlation of DC:ImC ratio with clinical objective response [ Designated as safety issue: No ]
  • Correlation of the extent of change of the DC:ImC ratio with tretinoin dose and tretinoin blood levels [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the ratio of dendritic cells (DC) to circulating immature cells (ImC) before and after treatment with 3 different doses of tretinoin in patients with stage IV renal cell cancer.
  • Assess in vitro immune response assays to tetanus toxoid and influenza virus peptide before and after treatment with tretinoin and interleukin-2 in these patients.

Secondary

  • Determine the frequency of treatment-related side effects in these patients.
  • Determine clinical objective response and progression-free survival of patients treated with this regimen.
  • Correlate DC:ImC ratio with clinical objective response in patients treated with this regimen.
  • Correlate the extent of change of the DC:ImC ratio with tretinoin dose and tretinoin blood levels in these patients.

OUTLINE: This is a randomized, open-label study. Specimens are stratified according to patient prognostic factors, tumor bulk, and extent of dendritic cell to circulating immature cell ratio derangement. Patients are randomized to 1 of 3 tretinoin doses.

Patients receive oral tretinoin three times daily on days 1-7 of week 1. Patients then receive interleukin-2 subcutaneously on days 1-5 of weeks 3-8. Treatment repeats every 10-11 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 27-36 patients (9-12 per treatment arm) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell cancer

    • Stage IV disease
    • Histology with clear cell component
  • Metastatic OR incompletely resected disease
  • Non-measurable disease allowed
  • Underwent complete or partial nephrectomy more than 90 days ago

    • No unresected primary cancer
  • No more than 2 of the following adverse factors:

    • Hemoglobin < 10.0 g/dL
    • Corrected calcium > upper limit of normal (ULN)
    • Lactic dehydrogenase > 1.5 times ULN
    • ECOG performance status 2
  • Brain metastasis allowed provided more than 90 days of clinical and radiologic stability after the end of its active treatment

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • See Disease Characteristics
  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • See Disease Characteristics
  • SGOT < 3 times normal
  • Bilirubin < 2 times normal

Renal

  • See Disease Characteristics
  • Creatinine clearance > 40 mL/min

Cardiovascular

  • None of the following cardiovascular conditions within the past year:

    • Uncontrolled hypertension
    • Myocardial infarction
    • Unstable angina
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Class II-IV peripheral vascular disease within the past year
    • Other clinically significant cardiovascular disease

Immunologic

  • No history of immunodeficiency disease
  • No HIV infection
  • No ongoing serious infection

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use two methods of effective contraception during and for 1 month (for women) or 6 months (for men) after study treatment
  • Other prior malignancy allowed provided there is no evidence of active disease
  • No other medical contraindication to tretinoin or interleukin-2
  • No serious non-healing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 60 days since prior immunotherapy

Chemotherapy

  • At least 60 days since prior cytotoxic chemotherapy

Endocrine therapy

  • See Radiotherapy
  • No prior corticosteroids at > physiologic replacement doses for > 3 days within the past 90 days
  • Concurrent tamoxifen, toremifene, megestrol, or gonadotropin-releasing hormone agonists allowed
  • Concurrent inhaled steroids allowed

Radiotherapy

  • More than 7 days since prior external-beam radiotherapy

    • No steroid requirement during radiotherapy

Surgery

  • See Disease Characteristics
  • At least 30 days since other prior debulking surgery

Other

  • Prior adjuvant therapy for resected, synchronous stage IV disease allowed
  • Prior adjuvant therapy allowed

    • Study therapy is not to be used as adjuvant therapy for completely resected late (> 1 year until identification) solitary site of disease metastasis or non-metastatic disease
  • No prior participation in this clinical study
  • At least 60 days since other prior anticancer drugs
  • Concurrent seizure medication allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100906

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: Mayer Fishman, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00100906     History of Changes
Other Study ID Numbers: CDR0000407544, MCC-13920, MCC-IRB-102626
Study First Received: January 6, 2005
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
clear cell renal cell carcinoma

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
Aldesleukin
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012