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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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00075491
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Vinay K. Puduvalli
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Additional Details

PRIMARY OBJECTIVES:

  • I. Compare the efficacy of neoadjuvant and adjuvant fenretinide vs.#46;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.

Arms & Interventions

Arms

Experimental: Arm I (fenretinide, surgery)

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

Active Comparator: Arm II (surgery)

Patients undergo surgical resection.

Interventions

Drug: - fenretinide

Given orally

Procedure: - therapeutic conventional surgery

Undergo surgery

Other: - pharmacological study

Correlative studies

Other: - laboratory biomarker analysis

Correlative studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Address

M D Anderson Cancer Center

Houston, Texas, 77030

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