Suspended

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

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What is being tested

fenretinide

+ therapeutic conventional surgery
+ pharmacological study
Drug
Procedure
Other
Who is being recruted

Adult Giant Cell Glioblastoma
+1

+ Adult Glioblastoma
+ Adult Gliosarcoma
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2003

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 24, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

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 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.

Official TitleA 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 
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
42 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
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)


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection.
Group II
Active Comparator
Patients undergo surgical resection.
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
M D Anderson Cancer CenterHouston, United StatesSee the location

SuspendedOne Study Center