Childhood Malignant Fibrous Histiocytoma of BonePhase 1NCT00450736
Celecoxib and Radiation Therapy in Treating Patients With Stage II or Stage III Soft Tissue Sarcoma of the Arm, Hand, Leg, or Foot That Has Been Removed by Surgery
A Phase 1 study testing celecoxib, adjuvant therapy and radiation therapy in people with Childhood Malignant Fibrous Histiocytoma of Bone and Sarcoma, run by University of Miami at 1 site in United States.
Trial summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma
- What is being tested?
- celecoxib, adjuvant therapy and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to May 2009
- Phase
- Phase 1
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma of the extremity, including the following disease types:
- Liposarcoma
- Leiomyosarcoma
- Synovial cell sarcoma
- Malignant fibrous histiocytoma
- Spindle cell sarcoma
- Fibrosarcoma
- Chondrosarcoma
- Angiosarcoma
- Hemangiopericytoma
- Neurofibrosarcoma
- The following disease types are excluded:
- Kaposi's sarcoma
- Rhabdomyosarcoma
- Dermatofibrosarcoma
- Epithelioid cell sarcoma
- Ewing's sarcoma
- Osteosarcoma
- Intermediate- or high-grade tumor ≥ 5.0 cm in 1 dimension (stage II or III disease)
- Locally resected disease
- One prior wide local excision of the sarcoma in the same location of the extremity within the past 6 months allowed
- Prior neoadjuvant chemotherapy (of ≤ 3 courses), followed by a limb-sparing surgical resection of sarcoma found to have < 90% pathological tumor necrosis allowed
- Prior resection of an extremity mass that is subsequently found to be a sarcoma meeting study criteria, followed by ≤ 3 courses of chemotherapy (independent of the percentage of pathological tumor necrosis) allowed
- No evidence of nodal or distant metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- WBC ≥ 3,000/mm³
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Calcium ≤ 1.3 times ULN
- No prior malignancy except cutaneous nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for at least 5 years
- No history of allergic reaction to sulfonamides or NSAIDs
- No known hypersensitivity to celecoxib or any component of its formulation
- No known HIV positivity
- No known coronary artery disease
- No cardiac event of any kind within the past 6 months
- No concurrent unstable cardiac status
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the extremity requiring radiation for this study
- No prior systemic chemotherapy for a malignant tumor
- No concurrent dilantin or lithium carbonate
- No other concurrent prescription or over-the-counter nonsteroidal anti-inflammatory agents (NSAIDs)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
About this study
Official title: A Phase I Trial of Postoperative Radiation With Dose-Escalation of A Cox-2 Inhibitor, Celebrex™ (CELECOXIB) in Patients With Soft Tissue Sarcoma of the Extremity
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with radiation therapy in treating patients with stage II or stage III soft tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of adjuvant celecoxib administered with radiotherapy in patients with resected stage II or III soft tissue sarcoma of the extremity.
OUTLINE: This is a dose-escalation study of celecoxib.
Beginning within 10 weeks of the most recent resection, patients undergo standard radiotherapy once daily, 5 days a week, in weeks 1-7. Patients also receive oral celecoxib twice daily in weeks 1-7 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. A maximum of 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
- Being tested
- celecoxib, adjuvant therapy, radiation therapy
- Keywords
- chondrosarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, childhood angiosarcoma, childhood fibrosarcoma, childhood leiomyosarcoma, childhood liposarcoma, childhood neurofibrosarcoma, childhood synovial sarcoma, nonmetastatic childhood soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, childhood malignant hemangiopericytoma, localized childhood malignant fibrous histiocytoma of bone
- Medical subject headings
- Sarcoma, Chondrosarcoma, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Neurofibrosarcoma, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
adjuvant therapyProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: celecoxib; Procedure: adjuvant therapy; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local failure
Measured: 3 years
Regional relapse
Measured: 3 years
Distant failure
Measured: 3 years
Overall survival
Measured: 3 years
Progression-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startMar 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Malignant Fibrous Histiocytoma of BoneStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron H. Wolfson, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450736
- Sponsor's protocol ID
- 20030283
- Other IDs
- SCCC-2003053, WIRB-20051240
- Status last verified
- Dec 2016
- First submitted
- 20 Mar 2007
- Last updated
- 15 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Postoperative Radiation With Dose-Escalation of A Cox-2 Inhibitor, Celebrex™ (CELECOXIB) in Patients With Soft Tissue Sarcoma of the Extremity
- ClinicalTrials.gov ID
- NCT00450736
- Acronym / sponsor ID
- 20030283
- Keywords
- chondrosarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, childhood angiosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Mar 2007 (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.
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with radiation therapy in treating patients with stage II or stage III soft tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of adjuvant celecoxib administered with radiotherapy in patients with resected stage II or III soft tissue sarcoma of the extremity.
OUTLINE: This is a dose-escalation study of celecoxib.
Beginning within 10 weeks of the most recent resection, patients undergo standard radiotherapy once daily, 5 days a week, in weeks 1-7. Patients also receive oral celecoxib twice daily in weeks 1-7 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. A maximum of 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: celecoxib, Procedure: adjuvant therapy, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 | Single Arm |
| adjuvant therapy | Procedure or surgery | Single Arm |
| radiation therapy | Radiation | Single Arm |
Primary outcome
Local failure
Time frame: 3 years
Regional relapse
Time frame: 3 years
Distant failure
Time frame: 3 years
Overall survival
Time frame: 3 years
Progression-free survival
Time frame: 3 years
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 15 Dec 2016.
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.
Aaron H. Wolfson, MD study chair
University of Miami Sylvester Comprehensive 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 1 study testing celecoxib, adjuvant therapy and radiation therapy in people with Childhood Malignant Fibrous Histiocytoma of Bone and Sarcoma, run by University of Miami 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?
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 15 Dec 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Local failure (time frame: 3 years). 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 15 Dec 2016.