NeoplasmsPhase 2NCT00165451
A Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
A Phase 2 study testing Thalidomide, Celecoxib and Etoposide in people with Neoplasms, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This study will use a combination of four oral drugs (thalidomide, cyclophosphamide, etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs are expected to target the blood vessels that supply the tumors with what they need to grow. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Thalidomide, Celecoxib and Etoposide
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Oct 2006
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with relapsed or progressive poor prognosis tumors for which no curative therapy exists.
- Histologic confirmation of disease at diagnosis or relapse.
- Brain stem glioma patients who have progressed after radiation therapy do not require histologic confirmation. Duration of symptoms at the time of diagnosis must be less than 3 months and should consist of cranial nerve deficits and/or ataxia and/or long tract signs.
- Prior radiation therapy and/or chemotherapy are permitted.
- Karnofsky Performance Status >50. For infants, the Lansky play scale >50% can be substituted.
- Life expectancy > 2 months.
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- No active uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on the common toxicity criteria.
- No known allergies to sulfonamides
- Adequate renal function: Serum Creatinine < 1.5 mg/dl or creatinine clearance or GFR > 70 ml/min.
- Adequate hepatic function: Total Bilirubin < 1.5 mg/dl; SGOT, SGPT, Alk Phos < 3x normal.(SGOT can be < 4x normal for patients on Zantac).
- Adequate bone marrow reserve: Hgb > 9.0 g/dl, Platelets > 75,000/mm3 (transfusion independent),WBC > 2000/mm3 and ANC > 1000/mm3.
- Patients receiving steroids and/or anti-seizure medications are eligible for this study.
Who cannot join
- Patients must not be pregnant or nursing, and all patients of child bearing age (both male and female) must be willing to practice birth control during and for 2 months after treatment with thalidomide. If the patient is unable to use oral contraceptives for medical reasons, 2 different barrier methods may be used if approved by the treating physician.
- No concurrent use of other investigational agents.
- Patients that have received more than 2 months of oral therapy with any of the agents used in this study will be ineligible. Standard administration of IV etoposide and cyclophosphamide, usually administered in 3-week cycles is permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
This study will use a combination of four oral drugs (thalidomide, cyclophosphamide, etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs are expected to target the blood vessels that supply the tumors with what they need to grow.
Read the detailed description
- Thalidomide will be given orally every evening and the daily dose will escalate until the patient reaches a dose on which they are comfortable and will given continuously for one year.
- Celecoxib will be given orally twice a day and escalated as tolerated for one year.
- Etoposide will be given orally once a day for 21 consecutive days. This medication will alternate with oral cyclophosphamide and will continue for one year.
- Cyclophosphamide will be given orally once a day for 21 consecutive days and as stated above will alternate with etoposide for one year.
- During the treatment, blood tests will be performed every three weeks except during the first 3 week cycle in which testing is performed every 2 weeks. Appropriate imaging studies will be performed every 9 weeks.
- The duration of treatment is one year unless the side effects are too harmful or the tumor grows. Treatment may be continued past one year if the drugs are well tolerated and disease progression has not occured.
- Conditions
- Neoplasms
- Being tested
- Thalidomide, Celecoxib, Etoposide, Cyclophosphamide
- Keywords
- Relapsed tumors, Progressive Poor Prognosis Tumors, Thalidomide, Celecoxib, Etoposide, Cyclophosphamide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Oral administration once daily at night starting at 3mg/Kg for 6 months.
CelecoxibDrug
Oral administration twice daily starting at 100mg/dose for 6 months.
EtoposideDrug
Also called VP-16
Oral administration once daily at night starting at 50mg/m2 3 weeks on and 3 weeks off for 6 months.
CyclophosphamideDrug
Oral administration once daily at night starting at 3.5mg/m2 3 weeks on and 3 weeks off for 6 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors.
Measured: 6 months
Secondary outcomes (3)
To obtain preliminary evidence of biologic activity of these four orally administered
Measured: 6 months
to evaluate and document side effects from chronic administration of these four drugs at the doses prescribed in this protocol
Measured: 6 months
to evaluate different radiographic techniques as markers of tumor response.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2001
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Mark W. Kieran, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165451
- Sponsor's protocol ID
- 01-046
- Status last verified
- Jul 2011
- First submitted
- 9 Sep 2005
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kieran MW, Turner CD, Rubin JB, Chi SN, Zimmerman MA, Chordas C, Klement G, Laforme A, Gordon A, Thomas A, Neuberg D, Browder T, Folkman J. A feasibility trial of antiangiogenic (metronomic) chemotherapy in pediatric patients with recurrent or progressive cancer. J Pediatr Hematol Oncol. 2005 Nov;27(11):573-81. doi: 10.1097/01.mph.0000183863.10792.d4.
PubMed 16282886
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
- ClinicalTrials.gov ID
- NCT00165451
- Acronym / sponsor ID
- 01-046
- Conditions
- Neoplasms
- Keywords
- Relapsed tumors, Progressive Poor Prognosis Tumors, Thalidomide, Celecoxib, Etoposide, Cyclophosphamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 14 Sep 2005 (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 study will use a combination of four oral drugs (thalidomide, cyclophosphamide, etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs are expected to target the blood vessels that supply the tumors with what they need to grow.
Detailed description
- Thalidomide will be given orally every evening and the daily dose will escalate until the patient reaches a dose on which they are comfortable and will given continuously for one year.
- Celecoxib will be given orally twice a day and escalated as tolerated for one year.
- Etoposide will be given orally once a day for 21 consecutive days. This medication will alternate with oral cyclophosphamide and will continue for one year.
- Cyclophosphamide will be given orally once a day for 21 consecutive days and as stated above will alternate with etoposide for one year.
- During the treatment, blood tests will be performed every three weeks except during the first 3 week cycle in which testing is performed every 2 weeks. Appropriate imaging studies will be performed every 9 weeks.
- The duration of treatment is one year unless the side effects are too harmful or the tumor grows. Treatment may be continued past one year if the drugs are well tolerated and disease progression has not occured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Patients with relapsed or progressive poor prognosis tumors for which no curative therapy exists.
- Histologic confirmation of disease at diagnosis or relapse.
- Brain stem glioma patients who have progressed after radiation therapy do not require histologic confirmation. Duration of symptoms at the time of diagnosis must be less than 3 months and should consist of cranial nerve deficits and/or ataxia and/or long tract signs.
- Prior radiation therapy and/or chemotherapy are permitted.
- Karnofsky Performance Status >50. For infants, the Lansky play scale >50% can be substituted.
Key exclusion criteria (3 listed)
- Patients must not be pregnant or nursing, and all patients of child bearing age (both male and female) must be willing to practice birth control during and for 2 months after treatment with thalidomide. If the patient is unable to use oral contraceptives for medical reasons, 2 different barrier methods may be used if approved by the treating physician.
- No concurrent use of other investigational agents.
- Patients that have received more than 2 months of oral therapy with any of the agents used in this study will be ineligible. Standard administration of IV etoposide and cyclophosphamide, usually administered in 3-week cycles is permitted.
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 |
|---|---|---|
| ThalidomideOral administration once daily at night starting at 3mg/Kg for 6 months. | Drug | – |
| CelecoxibOral administration twice daily starting at 100mg/dose for 6 months. | Drug | – |
| EtoposideAlso: VP-16Oral administration once daily at night starting at 50mg/m2 3 weeks on and 3 weeks off for 6 months. | Drug | – |
| CyclophosphamideOral administration once daily at night starting at 3.5mg/m2 3 weeks on and 3 weeks off for 6 months. | Drug | – |
Primary outcome
To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors.
Time frame: 6 months
3 secondary outcomes
To obtain preliminary evidence of biologic activity of these four orally administered
Time frame: 6 months
to evaluate and document side effects from chronic administration of these four drugs at the doses prescribed in this protocol
Time frame: 6 months
to evaluate different radiographic techniques as markers of tumor response.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
- Results publication: PubMed 16282886Kieran MW, Turner CD, Rubin JB, Chi SN, Zimmerman MA, Chordas C, Klement G, Laforme A, Gordon A, Thomas A, Neuberg D, Browder T, Folkman J. A feasibility trial of antiangiogenic (metronomic) chemotherapy in pediatric patients with recurrent or progressive cancer. J Pediatr Hematol Oncol. 2005 Nov;27(11):573-81. doi: 10.1097/01.mph.0000183863.10792.d4.
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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 principal investigator
Dana-Farber Cancer Institute
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 Thalidomide, Celecoxib and Etoposide in people with Neoplasms, run by Dana-Farber Cancer Institute 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 12 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jul 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors. (time frame: 6 months). 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 NCT00165451, 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 7 Jul 2011; AzTrials last refreshed its copy on 8 Nov 2026.