Adult Giant Cell GlioblastomaPhase 2NCT00075491
Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
A Phase 2 study testing fenretinide, therapeutic conventional surgery and pharmacological study in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
- What is being tested?
- fenretinide, therapeutic conventional surgery and pharmacological study
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 34Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Being tested
- fenretinide, therapeutic conventional surgery, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenretinideDrug
Also called fenretinimide, McN-R-1967
Given orally
therapeutic conventional surgeryProcedure or surgery
Undergo surgery
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (fenretinide, surgery) | Experimental | Patients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection. Receives: Drug: fenretinide; Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
| Arm II (surgery) | Active comparator | Patients undergo surgical resection. Receives: Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: Up to 6 months
Plasma and tissue concentrations of fenretinide and its metabolite, 4-MPR using high-performance liquid chromatography (HPLC) assay
Measured: At baseline, and at 1, 7, 14, and 21 days
Tumor apoptotic index after fenretinide treatment by immunohistochemistry
Measured: At the time of surgery
Correlation between tumor apoptotic index with serum and tissue fenretinide levels
Measured: At the time of surgery
Correlation of time to progression with drug levels and apoptotic index
Measured: Up to 2 years
Secondary outcomes (5)
Fenretinide effects on retinol, RBP, retinoid receptor levels and IGF-1
Measured: Up to 21 days (course 1 and 4)
Fenretinide activity using magnetic resonance spectroscopy (MRS)
Measured: At the time of surgery
Radiological response
Measured: Up to 2 years
Overall survival
Measured: Up to 2 years
Unexpected toxicity associated with fenretinide as assessed by CTC version 3.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2004 (estimated)
- Study startDec 2003
- Primary completionMar 2005
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Giant Cell GlioblastomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vinay K. Puduvalli, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075491
- Sponsor's protocol ID
- NCI-2012-02566
- Other IDs
- ID02-701, R21CA097767, CDR0000346722
- Status last verified
- Jan 2013
- First submitted
- 9 Jan 2004
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00075491
- Acronym / sponsor ID
- NCI-2012-02566
- Conditions
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2003
- Primary completion
- Mar 2005 (actual)
- First posted
- 12 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (fenretinide, surgery) | Experimental | Drug: fenretinide, Procedure: therapeutic conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive neoadjuvant oral fenretinide twice daily for 1 week and then undergo surgical resection. |
| Arm II (surgery) | Active comparator | Procedure: therapeutic conventional surgery, Other: pharmacological study, Other: laboratory biomarker analysisPatients undergo surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 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
- No progressive symptoms requiring urgent surgery
- Performance status - Karnofsky 70-100%
- More than 8 weeks
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenretinideAlso: fenretinimide, McN-R-1967Given orally | Drug | Arm I (fenretinide, surgery) |
| therapeutic conventional surgeryUndergo surgery | Procedure or surgery | Arm I (fenretinide, surgery), Arm II (surgery) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (fenretinide, surgery), Arm II (surgery) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (fenretinide, surgery), Arm II (surgery) |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinay K. Puduvalli principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fenretinide, therapeutic conventional surgery and pharmacological study in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.