Central Nervous System Tumor, PediatricPhase 2NCT00357500
Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer
A Phase 2 study testing celecoxib, cyclophosphamide and etoposide in people with Central Nervous System Tumor, Pediatric and Leukemia, run by Dana-Farber Cancer Institute at 10 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide, celecoxib, and fenofibrate may stop the growth of cancer cells by blocking blood flow to the cancer. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Central Nervous System Tumor, Pediatric, Leukemia, Lymphoma
- What is being tested?
- celecoxib, cyclophosphamide and etoposide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2005to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed cancer (at diagnosis or relapse), including any of the following:
- Leukemia and/or lymphoma (closed to accrual)
- Bone tumor (e.g., Ewing's sarcoma or osteosarcoma) (closed to accrual)
- Neuroblastoma (closed to accrual)
- High-grade glial tumor
- Low-grade glial tumor
- Ependymoma
- Medulloblastoma and/or primitive neuroectodermal tumor (PNET)
- Miscellaneous tumor (closed to accrual)
- Brain stem glioma, defined as intrinsic tumors of the pons causing diffuse enlargement
- Brain stem glioma that progressed after radiotherapy does not require histological confirmation
- Duration of symptoms at the time of diagnosis must be < 3 months
- Symptoms should consist of cranial nerve deficits, ataxia, and/or long tract signs
- Relapsed or progressive poor prognosis disease for which no available curative therapy exists
PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100% OR Lansky play scale 50-100% (for infants)
- Life expectancy > 2 months
- Platelet count > 75,000/mm^3 (transfusion independent)
- Absolute neutrophil count > 1,000/mm^3 (in patients without bone marrow disease)
- Hemoglobin ≥ 9.0 g/dL
- Creatinine < 1.5 mg/dL OR creatinine clearance or glomerular filtration rate ≥ 70 mL/min
- Bilirubin ≤ 1.5 mg/dL
- SGPT ≤ 3 times normal
- SGOT ≤ 3 times normal (4 times normal for patients on ranitidine hydrochloride)
- Alkaline phosphatase ≤ 3 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception during and for 2 months after completion of study treatment
- Must be willing to participate in the Celgene STEPS® program
- Recent thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism) allowed if patient is clinically stable and the thromboembolic event occurred > 3 weeks prior to study entry
- No active infection
- No active uncontrolled cardiac, hepatic, renal, or psychiatric disease ≥ grade 3
- No known allergies to sulfonamides
- No concurrent illness that would obscure toxicity or dangerously alter drug metabolism
- No other serious medical illness
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- Prior chemotherapy and/or radiotherapy allowed
- Prior celecoxib allowed
- Prior standard-dose IV etoposide and cyclophosphamide administered in 3-week courses allowed
- No prior oral therapy with etoposide, thalidomide, cyclophosphamide, or fenofibrate for > 2 months in duration
- No other concurrent investigational agents
- No other concurrent nonsteroidal anti-inflammatory drugs
- Concurrent steroids and/or antiseizure medications allowed
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Miami Children's Hospital
Miami, Florida, 33155-4069
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
NYU Cancer Institute at New York University Medical Center
New York, New York, 10016
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Maine Medical Center Research Institute
Scarborough, Maine, 04074-7205
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Anti-Angiogenic Chemotherapy: A Phase II Trial of the Oral 5-Drug Regimen (Thalidomide, Celecoxib, Fenofibrate, Etoposide and Cyclophosphamide) in Patients With Relapsed or Progressive Cancer
RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide, celecoxib, and fenofibrate may stop the growth of cancer cells by blocking blood flow to the cancer. Celecoxib also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with thalidomide, celecoxib, and fenofibrate may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving etoposide and cyclophosphamide together with thalidomide, celecoxib, and fenofibrate works in treating young patients with relapsed or progressive cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the activity of etoposide, cyclophosphamide, thalidomide, celecoxib, and fenofibrate, in terms of prolonging the time to disease progression, in young patients with relapsed or progressive cancer.
Secondary
- Determine, preliminarily, the biologic activity of this regimen, in terms of tumor response and overall survival, in these patients.
- Determine the toxicity of this regimen in these patients.
- Evaluate different radiographic techniques as markers of tumor response in these patients.
- Evaluate the predictive ability of in vitro correlative studies as markers of tumor response.
STATISTICAL DESIGN: Patients were classified into one of 8 strata according to diagnosis: leukemia/lymphoma, bone tumors, neuroblastoma, high grade glial tumors, low grade glial tumors, ependymoma, medulloblastoma/PNET, and miscellaneous. A two-stage design for each disease stratum was planned. The accrual goal at the end of the two-stage design was 20 subjects for each stratum. A stopping rule was applied after the accrual of the first 10 eligible subjects enrolled in each disease stratum. If 1 or more patients in the first 10 evaluable patients were alive and progression-free at 27 weeks and have tolerated therapy then accrual to stage two would proceed. Among 20 patients within a stratum, if 3 or more patients met primary endpoint then regimen would be considered successful. The probability of concluding the treatment is feasible is 0.95 if true success rate is 30% and 0.07 if true succes rate is 5%. Overall accrual target was 80-160 patients. Please see published manuscript (Robison et al Pediatr Blood Cancer 2014) for results within disease strata.
- Conditions
- Central Nervous System Tumor, Pediatric, Leukemia, Lymphoma, Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- celecoxib, cyclophosphamide, etoposide, fenofibrate, thalidomide
- Keywords
- Metronomic, antiangiogenic
- Medical subject headings
- Central Nervous System Neoplasms, Leukemia, Lymphoma, Neuroblastoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
cyclophosphamideDrug
etoposideDrug
fenofibrateDrug
thalidomideDrug
| Study group | Role | What they receive |
|---|---|---|
| 5-drug metronomic antiangiogenic regimen | Experimental | Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2). Receives: Drug: celecoxib; Drug: cyclophosphamide; Drug: etoposide; Drug: fenofibrate; Drug: thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy Completion Rate
Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Measured: 27 weeks
Secondary outcomes (3)
27-Week Progression-Free Survival
27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Measured: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
27-Week Overall Survival
27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods.
Measured: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
Best Response
As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Measured: Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startJan 2005
- Primary completionFeb 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System Tumor, PediatricStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Boston Children's Hospital
- Responsible party
- Principal investigator, Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Mark W. Kieran, MD, PhD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357500
- Sponsor's protocol ID
- 04-343
- Other IDs
- P30CA006516, CDR0000487628
- Status last verified
- Sep 2014
- First submitted
- 26 Jul 2006
- Last updated
- 1 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Robison NJ, Campigotto F, Chi SN, Manley PE, Turner CD, Zimmerman MA, Chordas CA, Werger AM, Allen JC, Goldman S, Rubin JB, Isakoff MS, Pan WJ, Khatib ZA, Comito MA, Bendel AE, Pietrantonio JB, Kondrat L, Hubbs SM, Neuberg DS, Kieran MW. A phase II trial of a multi-agent oral antiangiogenic (metronomic) regimen in children with recurrent or progressive cancer. Pediatr Blood Cancer. 2014 Apr;61(4):636-42. doi: 10.1002/pbc.24794. Epub 2013 Oct 4.
PubMed 24123865
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Angiogenic Chemotherapy: A Phase II Trial of the Oral 5-Drug Regimen (Thalidomide, Celecoxib, Fenofibrate, Etoposide and Cyclophosphamide) in Patients With Relapsed or Progressive Cancer
- ClinicalTrials.gov ID
- NCT00357500
- Acronym / sponsor ID
- 04-343
- Conditions
- Central Nervous System Tumor, Pediatric, Leukemia, Lymphoma, Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- Metronomic, antiangiogenic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Boston Children's Hospital
- Study start
- Jan 2005
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jul 2006 (estimated)
- Results
- Posted 9 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide, celecoxib, and fenofibrate may stop the growth of cancer cells by blocking blood flow to the cancer. Celecoxib also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with thalidomide, celecoxib, and fenofibrate may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving etoposide and cyclophosphamide together with thalidomide, celecoxib, and fenofibrate works in treating young patients with relapsed or progressive cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the activity of etoposide, cyclophosphamide, thalidomide, celecoxib, and fenofibrate, in terms of prolonging the time to disease progression, in young patients with relapsed or progressive cancer.
Secondary
- Determine, preliminarily, the biologic activity of this regimen, in terms of tumor response and overall survival, in these patients.
- Determine the toxicity of this regimen in these patients.
- Evaluate different radiographic techniques as markers of tumor response in these patients.
- Evaluate the predictive ability of in vitro correlative studies as markers of tumor response.
STATISTICAL DESIGN: Patients were classified into one of 8 strata according to diagnosis: leukemia/lymphoma, bone tumors, neuroblastoma, high grade glial tumors, low grade glial tumors, ependymoma, medulloblastoma/PNET, and miscellaneous. A two-stage design for each disease stratum was planned. The accrual goal at the end of the two-stage design was 20 subjects for each stratum. A stopping rule was applied after the accrual of the first 10 eligible subjects enrolled in each disease stratum. If 1 or more patients in the first 10 evaluable patients were alive and progression-free at 27 weeks and have tolerated therapy then accrual to stage two would proceed. Among 20 patients within a stratum, if 3 or more patients met primary endpoint then regimen would be considered successful. The probability of concluding the treatment is feasible is 0.95 if true success rate is 30% and 0.07 if true succes rate is 5%. Overall accrual target was 80-160 patients. Please see published manuscript (Robison et al Pediatr Blood Cancer 2014) for results within disease strata.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-drug metronomic antiangiogenic regimen | Experimental | Drug: celecoxib, Drug: cyclophosphamide, Drug: etoposide, Drug: fenofibrate, Drug: thalidomideThalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2). |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| celecoxib | Drug | 5-drug metronomic antiangiogenic regimen |
| cyclophosphamide | Drug | 5-drug metronomic antiangiogenic regimen |
| etoposide | Drug | 5-drug metronomic antiangiogenic regimen |
| fenofibrate | Drug | 5-drug metronomic antiangiogenic regimen |
| thalidomide | Drug | 5-drug metronomic antiangiogenic regimen |
Primary outcome
Therapy Completion Rate
Time frame: 27 weeks
Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
3 secondary outcomes
27-Week Progression-Free Survival
Time frame: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
27-Week Overall Survival
Time frame: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.
Best Response
Time frame: Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24123865Robison NJ, Campigotto F, Chi SN, Manley PE, Turner CD, Zimmerman MA, Chordas CA, Werger AM, Allen JC, Goldman S, Rubin JB, Isakoff MS, Pan WJ, Khatib ZA, Comito MA, Bendel AE, Pietrantonio JB, Kondrat L, Hubbs SM, Neuberg DS, Kieran MW. A phase II trial of a multi-agent oral antiangiogenic (metronomic) regimen in children with recurrent or progressive cancer. Pediatr Blood Cancer. 2014 Apr;61(4):636-42. doi: 10.1002/pbc.24794. Epub 2013 Oct 4.
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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.
Mark W. Kieran, MD, PhD study chair
Dana-Farber Cancer Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing celecoxib, cyclophosphamide and etoposide in people with Central Nervous System Tumor, Pediatric and Leukemia, run by Dana-Farber Cancer Institute at 10 sites 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?
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: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Yes. Results are posted in the registry (first posted 9 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Therapy Completion Rate (time frame: 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00357500, which also lists 1 linked publication.
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 1 Oct 2014.