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Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00075491
Recruitment Status : Terminated (Administratively complete.)
First Posted : January 12, 2004
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE January 9, 2004
First Posted Date  ICMJE January 12, 2004
Last Update Posted Date January 24, 2013
Study Start Date  ICMJE December 2003
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Progression-free survival (PFS) [ Time Frame: Up to 6 months ]
  • Plasma and tissue concentrations of fenretinide and its metabolite, 4-MPR using high-performance liquid chromatography (HPLC) assay [ Time Frame: At baseline, and at 1, 7, 14, and 21 days ]
  • Tumor apoptotic index after fenretinide treatment by immunohistochemistry [ Time Frame: At the time of surgery ]
  • Correlation between tumor apoptotic index with serum and tissue fenretinide levels [ Time Frame: At the time of surgery ]
  • Correlation of time to progression with drug levels and apoptotic index [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00075491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Fenretinide effects on retinol, RBP, retinoid receptor levels and IGF-1 [ Time Frame: Up to 21 days (course 1 and 4) ]
  • Fenretinide activity using magnetic resonance spectroscopy (MRS) [ Time Frame: At the time of surgery ]
  • Radiological response [ Time Frame: Up to 2 years ]
  • Overall survival [ Time Frame: Up to 2 years ]
  • Unexpected toxicity associated with fenretinide as assessed by CTC version 3.0 [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
Official Title  ICMJE A Phase II Evaluation With Correlative Studies Of Fenretinide (NSC 374551-4HPR) As A Single Agent In The Treatment Of Adult Patients With Recurrent Glioblastoma Multiforme
Brief Summary This randomized phase II trial is studying how well neoadjuvant and adjuvant fenretinide works compared to adjuvant fenretinide alone in treating patients who are undergoing surgical resection for recurrent glioblastoma multiforme. Chemotherapy drugs, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether neoadjuvant and adjuvant fenretinide is more effective than adjuvant fenretinide alone
Detailed Description

PRIMARY OBJECTIVES:

I. Compare the efficacy of neoadjuvant and adjuvant fenretinide vs adjuvant fenretinide alone, in terms of 6-month progression-free survival, in patients with recurrent glioblastoma multiforme undergoing surgical resection II. Correlate the serum and glioma tissue pharmacology of this drug with clinical response in patients treated with these regimens.

III. Determine whether this drug induces apoptosis in glioma tissue in patients treated with these regimens.

IV. Correlate the apoptotic index with tissue and serum concentration and clinical response in patients treated with these regimens.

V. Compare radiological response, overall survival, and unexpected toxicity in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.

Arm II: Patients undergo surgical resection.

Beginning two weeks after surgery, all patients receive adjuvant oral fenretinide twice daily on weeks 1 and 4. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-46 patients (10-23 per treatment arm) will be accrued for this study within 7-46 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
Intervention  ICMJE
  • Drug: fenretinide
    Given orally
    Other Names:
    • fenretinimide
    • McN-R-1967
  • Procedure: therapeutic conventional surgery
    Undergo surgery
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE
  • Experimental: Arm I (fenretinide, surgery)
    Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.
    Interventions:
    • Drug: fenretinide
    • Procedure: therapeutic conventional surgery
    • Other: pharmacological study
    • Other: laboratory biomarker analysis
  • Active Comparator: Arm II (surgery)
    Patients undergo surgical resection.
    Interventions:
    • Procedure: therapeutic conventional surgery
    • Other: pharmacological study
    • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)
42
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed glioblastoma multiforme after initial tumor resection
  • Radiologically evident recurrent tumor after prior radiotherapy OR after treatment for no more than 2 prior relapses

    • Enhancing or nonenhancing recurrent disease by MRI
  • No progressive symptoms requiring urgent surgery
  • Performance status - Karnofsky 70-100%
  • More than 8 weeks
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • PT/PTT no greater than upper limit of normal
  • SGPT no greater than 2.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal
  • Bilirubin less than 1.5 mg/dL
  • BUN no greater than 1.5 times normal
  • Creatinine no greater than 1.5 times normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 2 months after study participation
  • Amylase and lipase normal
  • No active infection
  • No other disease that would obscure toxicity or dangerously alter drug metabolism
  • No other concurrent serious medical illness
  • Not at risk from any study treatment delays
  • Able to swallow fenretinide capsules
  • Recovered from all prior chemotherapy
  • Approximately 2 weeks since prior vincristine
  • Approximately 6 weeks since prior nitrosoureas
  • Approximately 3 weeks since prior procarbazine
  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy
  • See Disease Characteristics
  • At least 1 week since prior vitamin A
  • At least 1 week since prior isotretinoin (Accutane®)
  • No concurrent vitamin A during and for 2 weeks after study participation
  • No concurrent antioxidants (e.g., ascorbic acid or vitamin E)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00075491
Other Study ID Numbers  ICMJE NCI-2012-02566
ID02-701
R21CA097767 ( U.S. NIH Grant/Contract )
CDR0000346722 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vinay K. Puduvalli M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP