Childhood Desmoplastic Small Round Cell TumorPhase 2NCT00030667
Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
A Phase 2 study testing imatinib mesylate, laboratory biomarker analysis and pharmacological study in people with Childhood Desmoplastic Small Round Cell Tumor and Childhood Synovial Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Childhood Desmoplastic Small Round Cell Tumor, Childhood Synovial Sarcoma, Gastrointestinal Stromal Tumor
- What is being tested?
- imatinib mesylate, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Dec 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed solid tumors including the following:
- Ewing's sarcoma
- Bone or soft tissue primitive neuroectodermal tumor
- Osteosarcoma
- Neuroblastoma
- Desmoplastic small round cell tumor
Show all 50Show fewer
- Synovial cell sarcoma
- Gastrointestinal stromal tumor (GIST)
- Metastatic pulmonary disease eligible
- No pleural effusion of any size or definite radiologic evidence of pleural-based disease
- Recurrent or refractory to conventional therapy
- GIST eligible at initial presentation
- Tumor tissue blocks must be available
- At least 1 measurable lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Lesions assessable only by radionuclide scan are not considered measurable
- Performance status - Lansky 50-100% (≤ 10 years of age)
- Performance status - Karnofsky 50-100% (> 10 years of age)
- At least 2 months
- Absolute neutrophil count ≥ 1,000/mm^3*
- Platelet count ≥ 75,000/mm^3* (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL* (RBC transfusions allowed)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 2.5 times ULN
- INR < 1.5
- PTT ≤ ULN
- Fibrinogen ≥ lower limit of normal
- Creatinine normal for age
- Glomerular filtration rate ≥ 70 mL/min
- No uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- At least 1 week since prior biologic therapy or immunotherapy and recovered
- At least 1 week since prior growth factors
- No concurrent immunomodulating agents
- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- No concurrent steroids
- Recovered from prior radiotherapy
- At least 2 weeks since prior local palliative radiotherapy (small port)
- At least 3 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of pelvis
- At least 6 weeks since other prior substantial bone marrow radiation
- No concurrent radiotherapy during first course of treatment
- Concurrent palliative radiotherapy to local painful lesions allowed after first course of treatment provided there is no evidence of disease progression and at least 1 measurable lesion remains outside radiation port
- No concurrent therapeutic doses of warfarin
- No concurrent anticonvulsants that induce the cytochrome p450 enzyme system (e.g., phenytoin, carbamazepine, and phenobarbital)
- Concurrent benzodiazepines and gabapentin allowed
- Concurrent low-molecular weight heparin allowed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Arcadia, California, 91006-3776
About this study
Official title: A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Read the detailed description
OBJECTIVES:
- Determine the response rate of patients with relapsed or refractory pediatric solid tumors treated with imatinib mesylate.
II. Determine the toxicity of this drug in these patients. III. Determine the time to progression in patients treated with this drug. IV. Determine the pharmacokinetics of this drug in these patients. V. Correlate response with c-kit and platelet-derived growth factor receptor expression in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma/primitive neuroectodermal tumor vs osteosarcoma vs neuroblastoma vs other).
Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Conditions
- Childhood Desmoplastic Small Round Cell Tumor, Childhood Synovial Sarcoma, Gastrointestinal Stromal Tumor, Lung Metastases, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Being tested
- imatinib mesylate, laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Desmoplastic Small Round Cell Tumor, Gastrointestinal Stromal Tumors, Neuroectodermal Tumors, Primitive, Peripheral, Neuroblastoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Also called CGP 57148, Gleevec, Glivec
Given orally
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate, determined using the RECIST criteria
95% confidence interval will be computed.
Measured: Up to 2 years
Toxicity reported using the CTC version 2.0
Measured: Up to 2 years
Secondary outcomes (1)
Time to disease progression
Calculated by the method of Kaplan and Meier.
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 posted7 May 2003 (estimated)
- Study startMay 2002
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Desmoplastic Small Round Cell TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mason Bond, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030667
- Sponsor's protocol ID
- NCI-2012-01869
- Other IDs
- NCI-2012-01869, CDR0000069187, COG-ADVL0122, ADVL0122, ADVL0122, U10CA098543
- Status last verified
- Dec 2013
- First submitted
- 14 Feb 2002
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors
- ClinicalTrials.gov ID
- NCT00030667
- Acronym / sponsor ID
- NCI-2012-01869
- Conditions
- Childhood Desmoplastic Small Round Cell Tumor, Childhood Synovial Sarcoma, Gastrointestinal Stromal Tumor, Lung Metastases, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 7 May 2003 (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.
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Detailed description
OBJECTIVES:
- Determine the response rate of patients with relapsed or refractory pediatric solid tumors treated with imatinib mesylate.
II. Determine the toxicity of this drug in these patients. III. Determine the time to progression in patients treated with this drug. IV. Determine the pharmacokinetics of this drug in these patients. V. Correlate response with c-kit and platelet-derived growth factor receptor expression in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma/primitive neuroectodermal tumor vs osteosarcoma vs neuroblastoma vs other).
Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Drug: imatinib mesylate, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (50 listed)
- Histologically confirmed solid tumors including the following:
- Metastatic pulmonary disease eligible
- Recurrent or refractory to conventional therapy
- Tumor tissue blocks must be available
- At least 1 measurable lesion
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 |
|---|---|---|
| imatinib mesylateAlso: CGP 57148, Gleevec, GlivecGiven orally | Drug | Treatment (imatinib mesylate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (imatinib mesylate) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (imatinib mesylate) |
Primary outcome
Response rate, determined using the RECIST criteria
Time frame: Up to 2 years
95% confidence interval will be computed.
Toxicity reported using the CTC version 2.0
Time frame: Up to 2 years
1 secondary outcome
Time to disease progression
Time frame: Up to 2 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 Apr 2015.
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.
Mason Bond principal investigator
Children's Oncology Group
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 imatinib mesylate, laboratory biomarker analysis and pharmacological study in people with Childhood Desmoplastic Small Round Cell Tumor and Childhood Synovial Sarcoma, 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 50 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: finished, as of the sponsor's last update on 15 Apr 2015. 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?
Response rate, determined using the RECIST criteria (time frame: Up to 2 years). The study lists 2 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 Apr 2015.