Solid TumorsPhase 1NCT00165373
rhEndostatin Protein Involving Pediatric Patients With Cancer
A Phase 1 study testing rhEndostatin in people with Solid Tumors, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to determine the effect of rhEndostatin on the formation… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- rhEndostatin
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must have had a histological verification of solid tumor at the original diagnosis. For patients with brain stem gliomas and optic pathway tumors, the requirement for histological evaluation may be waived. The patient's disease must be considered refractory to conventional/standard therapy, or a disease for which no conventional therapy exists and is progressive. Patients must have measurable disease for this study.
- Agree to having a central venous access placed
- Be between 2 and 18, inclusive, years of age
- Aspartate aminotransferase and alanine aminotransferase less than 2.5 x ULN-
- Total bilirubin less than 2.0 x ULN
- Serum creatinine less than 2.0 mg/dL or a creatinine clearance or glomerular filtration rate less than 2 times normal for age
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- Absolute neutrophil count greater than or equal to 1,000/mm3
- Platelets greater than or equal to 100,000/mm3 (transfusion independent)
- Hemoglobin greater than 8.0 g/dL
- Have an estimated life expectancy of at least 3 months
- Have a Karnofsky performance status greater than 50 for patients aged 10 years or older and a Lansky performance status greater than 50 for patients aged 2 to less than 10 years
- Patients are required to have had an EKG, echocardiogram, and pulse oximetry within age-appropriate levels prior to starting therapy.
- If a woman or man of child producing potential, agree to use effective contraceptive methods (A negative pregnancy test within 72 hours before the administration of rhEndostatin protein will be required for women of childbearing potential.)
Who cannot join
- Patients with leukemia
- Be pregnant or nursing
- Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
- Have any condition that is likely to interfere with regular follow-up
- Have participated in any clinical trial involving conventional or investigational drugs or devices within 4 weeks prior to rhEndostatin protein administration
- Have received radiotherapy or chemotherapy within 4 weeks prior to rhEndostatin protein administration
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- Have received nitrosourea or mitomycin C less than 6 weeks prior to initiation of therapy
- Be receiving concurrent treatment with therapeutic doses of heparin or enoxaparin sodium (Lovenox®) (rhEndostatin protein has a heparin binding domain.)
- Have had major surgery within 2 weeks of starting rhEndostatin protein administration This does not include placement of a vascular access device.
- Have a history of bone marrow transplantation or extensive radiotherapy (craniospinal, total body, or radiotherapy to more than half of the pelvis) within the previous 4 months
- Have ionized calcium levels below the lower limits of normal
- Have a history of myocardial infarction within the last 6 months, angina pectoris/angina equivalent in the last 6 months (the patient may be on antianginal medications if the symptoms can be entirely controlled), or have uncontrolled congestive heart failure
- Have an active infection
- Have additional uncontrolled serious medical or psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I, Safety, Pharmacokinetic and Pharmacodynamic Study of rhEndostatin Protein Administered by Continuous Intravenous Infusion to Pediatric Patients With Cancer
The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to determine the effect of rhEndostatin on the formation of new blood vessel factors, and to perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells (cells in the body that help the tumor build more blood vessels).
Read the detailed description
- Patients will receive rhEndostatin intravenously continuously for 28 days and will be enrolled into one of 2 dosing groups.
- During the initial course of treatment, subjects will be evaluated for treatment-related side effects. If there are no side effects or disease progression, they may receive an additional 28 days of continuous rhEndostatin.
- During the infusion of rhEndostatin, blood samples will be collected before, during and after the drug is given to determine how much of the drug stays in the blood. Blood will be drawn on days 1, 8, 22 and 29. After the completion of therapy, a blood sample will be collected at least 3 days after to determine the level (if any) of rhEndostatin still in the patients blood.
- Blood and/or urine samples to determine immune reactions against rhEndostatin as well as molecules that tumors may use to stimulate new blood vessel growth will be drawn at the start of the study as well as after the completion of each 28-day cycle and completion of the study.
- When a tumor-specific marker that can be used to monitor the status of the disease is present, blood samples for the measurement marker will be obtained at the start of the study as well as after each cycle.
- Appropriate imaging studies (MRI, CT scan, x-ray) will be done after the completion of the first two 28-day cycles and then at the completion of each 28-day cycle for the duration of therapy.
- Treatment will be continued for 1 year and may be extended if the drugs are well tolerated and disease progression has not occured.
- Conditions
- Solid Tumors
- Being tested
- rhEndostatin
- Keywords
- pediatric solid tumors, rhEndostatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhEndostatinDrug
Given by continuous infustion for 28 days (one of two dosing groups) for a total of 2 cycles. Treatment can be extended if tolerated well.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of rhEndostatin protein in pediatric patients with recurrent or progressive cancer that is measurable and that is refractory to standard therapies.
Measured: 3 years
Secondary outcomes (1)
To determine how much of the drug stays in the blood of patients (pharmacokinetics)and to evaluate tumor response after treatment with rhEndostatin on this patient population.
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 posted14 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionJan 2005
- Study completionJan 2005
Why it stopped: Lack of drug supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Investigators
- Mark W Kieran, MD,PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165373
- Sponsor's protocol ID
- 02-222
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Safety, Pharmacokinetic and Pharmacodynamic Study of rhEndostatin Protein Administered by Continuous Intravenous Infusion to Pediatric Patients With Cancer
- ClinicalTrials.gov ID
- NCT00165373
- Acronym / sponsor ID
- 02-222
- Conditions
- Solid Tumors
- Keywords
- pediatric solid tumors, rhEndostatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of drug supply
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- Jan 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (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.
The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to determine the effect of rhEndostatin on the formation of new blood vessel factors, and to perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells (cells in the body that help the tumor build more blood vessels).
Detailed description
- Patients will receive rhEndostatin intravenously continuously for 28 days and will be enrolled into one of 2 dosing groups.
- During the initial course of treatment, subjects will be evaluated for treatment-related side effects. If there are no side effects or disease progression, they may receive an additional 28 days of continuous rhEndostatin.
- During the infusion of rhEndostatin, blood samples will be collected before, during and after the drug is given to determine how much of the drug stays in the blood. Blood will be drawn on days 1, 8, 22 and 29. After the completion of therapy, a blood sample will be collected at least 3 days after to determine the level (if any) of rhEndostatin still in the patients blood.
- Blood and/or urine samples to determine immune reactions against rhEndostatin as well as molecules that tumors may use to stimulate new blood vessel growth will be drawn at the start of the study as well as after the completion of each 28-day cycle and completion of the study.
- When a tumor-specific marker that can be used to monitor the status of the disease is present, blood samples for the measurement marker will be obtained at the start of the study as well as after each cycle.
- Appropriate imaging studies (MRI, CT scan, x-ray) will be done after the completion of the first two 28-day cycles and then at the completion of each 28-day cycle for the duration of therapy.
- Treatment will be continued for 1 year and may be extended if the drugs are well tolerated and disease progression has not occured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Must have had a histological verification of solid tumor at the original diagnosis. For patients with brain stem gliomas and optic pathway tumors, the requirement for histological evaluation may be waived. The patient's disease must be considered refractory to conventional/standard therapy, or a disease for which no conventional therapy exists and is progressive. Patients must have measurable disease for this study.
- Agree to having a central venous access placed
- Be between 2 and 18, inclusive, years of age
- Aspartate aminotransferase and alanine aminotransferase less than 2.5 x ULN-
- Total bilirubin less than 2.0 x ULN
Key exclusion criteria (14 listed)
- Patients with leukemia
- Be pregnant or nursing
- Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
- Have any condition that is likely to interfere with regular follow-up
- Have participated in any clinical trial involving conventional or investigational drugs or devices within 4 weeks prior to rhEndostatin protein administration
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 |
|---|---|---|
| rhEndostatinGiven by continuous infustion for 28 days (one of two dosing groups) for a total of 2 cycles. Treatment can be extended if tolerated well. | Drug | – |
Primary outcome
To assess the safety of rhEndostatin protein in pediatric patients with recurrent or progressive cancer that is measurable and that is refractory to standard therapies.
Time frame: 3 years
1 secondary outcome
To determine how much of the drug stays in the blood of patients (pharmacokinetics)and to evaluate tumor response after treatment with rhEndostatin on this patient population.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Lack of drug supply). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
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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 1 study testing rhEndostatin in people with Solid Tumors, 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 13 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Dec 2007. 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 was stopped early (reason given: Lack of drug supply). Results are not available in the source record.
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 assess the safety of rhEndostatin protein in pediatric patients with recurrent or progressive cancer that is measurable and that is refractory to standard therapies. (time frame: 3 years). 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 28 Dec 2007.