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Tretinoin and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: January 6, 2005   Last Updated: 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: Treatment, Open Label
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:
Study ID Numbers: CDR0000407544, MCC-13920, MCC-IRB-102626
Study First Received: January 6, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00100906     History of Changes
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:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Urogenital Neoplasms
Urologic Neoplasms
Antiviral Agents
Pharmacologic Actions
Carcinoma
Keratolytic Agents
Neoplasms
Neoplasms by Site
Aldesleukin
Anti-Retroviral Agents
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Tretinoin
Kidney Diseases
Adenocarcinoma
Dermatologic Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009