Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00085111
Bevacizumab in Treating Young Patients With Refractory Solid Tumors
A Phase 1 study testing bevacizumab in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial is studying the side effects and best dose of bevacizumab in treating young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Oct 2005
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed solid tumor at original diagnosis
- Measurable or evaluable* disease
- No known curative therapy exists
- No lymphomas or primary CNS tumors
- No history or clinical evidence of CNS metastasis by head CT scan
- Performance status - Karnofsky 50-100% (patients > 10 years of age)
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- Performance status - Lansky 50-100% (patients ≤ 10 years of age)
- At least 8 weeks
- Patients without bone marrow involvement:
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusion allowed)
- Patients with bone marrow metastases:
- Platelet count ≥ 75,000/mm^3 (transfusion independent)
- Granulocytopenia, anemia, and/or mild thrombocytopenia allowed
- No known bleeding diathesis or coagulopathy
- No known thrombophilic condition (e.g., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocystinemia, or antiphospholipid antibody syndrome)
- PT or PTT ≤ 1.2 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance or radioisotope glomerular filtrationrate ≥ 70 mL/min
- Creatinine based on age as follows:
- Creatinine ≤ 0.8 mg/dL (patients ≤ 5 years of age)
- Creatinine ≤ 1.0 mg/dL (patients 6 to 10 years of age)
- Creatinine ≤ 1.2 mg/dL (patients 11 to 15 years of age)
- Creatinine ≤ 1.5 mg/dL (patients > 15 years of age)
- No proteinuria
- 24-hour urine protein ≤ 500 mg
- No history of stroke
- No deep venous or arterial thrombosis within the past 3 months
- No uncontrolled hypertension
- Hypertension must be well-controlled with stable doses of medication for at least 2 weeks
- No history of myocardial infarction
- No severe or unstable angina
- No transient ischemic attack within the past 6 months
- No cerebrovascular accident within the past 6 months
- No other arterial thromboembolic event within the past 6 months
- No clinically significant or severe peripheral vascular disease
- No pulmonary embolism within the past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No chronic non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No uncontrolled seizures
- No uncontrolled infection
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Recovered from prior immunotherapy
- More than 1 week since prior growth factors
- At least 2 months since prior stem cell transplantation
- No evidence of active graft-vs-host disease
- At least 8 weeks since prior monoclonal antibody therapy
- At least 7 days since prior antineoplastic biologic agents
- No prior bevacizumab
- No concurrent prophylactic growth factors
- No other concurrent immunotherapy or biologic therapy
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- Recovered from prior radiotherapy
- At least 4 months since prior craniospinal radiotherapy
- At least 4 months since prior radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- At least 2 weeks since prior local palliative small-port radiotherapy
- No concurrent radiotherapy
- More than 28 days since prior major surgery
- At least 7 days since prior minor surgery (for limited purposes of tissue retrieval) and recovered
- At least 24 hours since prior placement of an indwelling IV catheter
- At least 1 week since prior full-dose anticoagulation therapy, including systemic thrombolytic agents, heparin, low-molecular weight heparin, and warfarin
- Local intralumenal anticoagulants (e.g., heparin or tissue plasminogen activator) allowed to maintain patency of preexisting, permanent, indwelling IV catheters or peripheral IV catheters for blood sampling
- More than 1 week since prior antipyretic and anti-inflammatory medications (except acetaminophen)
- No concurrent full-dose anticoagulation therapy
- No concurrent anti-inflammatory medication
- Concurrent acetaminophen allowed
- No other concurrent cancer therapy
- No other concurrent investigational agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
COG Phase I Consortium
Arcadia, California, 91006-3776
About this study
Official title: A Phase I Study of Bevacizumab in Refractory Solid Tumors
This phase I trial is studying the side effects and best dose of bevacizumab in treating young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerable dose (MTD) of bevacizumab by dose escalation to a maximum of 15mg/kg, even if MTD is not reached, administered as an intravenous infusion, every 2 weeks to children with refractory solid tumors.
II. To determine the dose-limiting toxicities (DLT) and other toxicities of bevacizumab given on this schedule.
III. To characterize the pharmacokinetic behavior of bevacizumab in children with refractory cancer.
SECONDARY OBJECTIVES:
- To preliminarily define the antitumor activity of bevacizumab within the confines of a phase I study.
II. To assess the biologic activity of bevacizumab by measuring levels of total serum VEGF, and parallel angiogenic markers V-CAM-1, ICAM-1, bFGF, and TSP-1 at baseline and at time points post therapy.
III. To explore the biologic effect of bevacizumab on circulating endothelial cells (CECs) and circulating endothelial cell precursors (CECPs).
IV. To determine in archival tumor tissue the expression of VEGF by immunohistochemistry and/or real time PCR.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Being tested
- bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Receives: Biological: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose defined based on the dose-limiting toxicities graded according to Common Terminology Criteria for Adverse Events v3.0
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startDec 2003
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Julia Bender, Principal investigator, COG Phase I Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085111
- Sponsor's protocol ID
- NCI-2012-01813
- Other IDs
- ADVL0314, COG-ADVL0314, CDR0000367299, NCI-04-C-0148, U01CA097452
- Status last verified
- Jun 2013
- First submitted
- 10 Jun 2004
- Last updated
- 5 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Bevacizumab in Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00085111
- Acronym / sponsor ID
- NCI-2012-01813
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2003
- Primary completion
- Oct 2005 (actual)
- First posted
- 11 Jun 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 phase I trial is studying the side effects and best dose of bevacizumab in treating young patients with refractory solid tumors. Monoclonal antibodies, such as bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerable dose (MTD) of bevacizumab by dose escalation to a maximum of 15mg/kg, even if MTD is not reached, administered as an intravenous infusion, every 2 weeks to children with refractory solid tumors.
II. To determine the dose-limiting toxicities (DLT) and other toxicities of bevacizumab given on this schedule.
III. To characterize the pharmacokinetic behavior of bevacizumab in children with refractory cancer.
SECONDARY OBJECTIVES:
- To preliminarily define the antitumor activity of bevacizumab within the confines of a phase I study.
II. To assess the biologic activity of bevacizumab by measuring levels of total serum VEGF, and parallel angiogenic markers V-CAM-1, ICAM-1, bFGF, and TSP-1 at baseline and at time points post therapy.
III. To explore the biologic effect of bevacizumab on circulating endothelial cells (CECs) and circulating endothelial cell precursors (CECPs).
IV. To determine in archival tumor tissue the expression of VEGF by immunohistochemistry and/or real time PCR.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: bevacizumabPatients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (76 listed)
- Histologically confirmed solid tumor at original diagnosis
- Measurable or evaluable* disease
- No known curative therapy exists
- No lymphomas or primary CNS tumors
- No history or clinical evidence of CNS metastasis by head CT scan
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 |
|---|---|---|
| bevacizumabAlso: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGFGiven IV | Biological | Arm I |
Primary outcome
Maximum tolerated dose defined based on the dose-limiting toxicities graded according to Common Terminology Criteria for Adverse Events v3.0
Time frame: 28 days
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 5 Jun 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.
Julia Bender principal investigator
COG Phase I Consortium
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 bevacizumab in people with Unspecified Childhood Solid Tumor, Protocol Specific, 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 76 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 5 Jun 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 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?
Maximum tolerated dose defined based on the dose-limiting toxicities graded according to Common Terminology Criteria for Adverse Events v3.0 (time frame: 28 days). 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 5 Jun 2013.