Diffuse Intrinsic Pontine GliomaPhase 2NCT00036569
A Phase II Study of Pegylated Interferon Alfa 2b (PEG-Intron(Trademark)) in Children With Diffuse Pontine Gliomas
A Phase 2 study testing adjuvant therapy and pegylated interferon alfa in people with Diffuse Intrinsic Pontine Glioma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Diffuse pontine gliomas are tumors on the pons portion of the brainstem. Their peak incidence is in children between 5 and 10 years old. Their location makes surgical resection impossible. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Diffuse Intrinsic Pontine Glioma
- What is being tested?
- adjuvant therapy and pegylated interferon alfa
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age: Patients must be less than or equal to 21 years of age.
- Histological diagnosis: Histologic confirmation is not required for this study. Patients must have a diffuse pontine glioma as diagnosed by magnetic resonance imaging (MRI) criteria below.
- Radiographic Appearance: Patients must have a diffuse intrinsic tumor with the epicenter presumed to be in the pons. The T-2 weighted sequence must reveal a diffuse signal abnormality involving at least 50 percent of the pons.
- Prior therapy: The patient must have received adequate radiation therapy. (Radiation must be completed between 2-10 weeks prior to the start of treatment with Peg-Intron (TM).
- Performance status: Patients should have an Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 (see below). Patients who are unable to walk because of paralysis, but who are up in a wheel chair will be considered ambulatory for the purpose of calculating the performance score.
- ECOG Performance Status:
Show all 23Show fewer
- Score--Clinical Status
- 0--Asymptomatic
- -Symptomatic, fully ambulatory
- -Symptomatic, in bed less than 50 percent of the day
- -Symptomatic, in bed greater than 50 percent of the day but not bedridden
- -Bedridden
- Hematological function: Patients must have adequate bone marrow function defined as a peripheral absolute granulocyte count of greater than 1000/mm^3, hemoglobin greater than 8 gm/dL, and platelet count greater than 100,000/mm^3. Patients may be transfused with red blood cells (RBC's) or platelets to achieve these parameters.
- Hepatic function: Patients must have adequate liver function, defined as total bilirubin less than 2.5 times the upper limit of normal, direct bilirubin within normal limits, and serum glutamic pyruvic transaminase (SGPT) less than 2.0 times the upper limit of normal. Patients with Gilbert Syndrome are excluded from both the total and direct bilirubin requirements. (Gilbert Syndrome is found in 3-10 percent of the general population and is characterized by mild, chronic hyperbilirubinemia in the absence of liver disease or overt hemolysis.)
- Renal function: Patients must have an age-adjusted normal serum creatinine (see below) OR a creatinine clearance greater than or equal to 60 mL/min/1.73 m^2.
- Age (Years)---Maximum Serum Creatinine (mg/dl)
- less than or equal to 5---0.8
- greater than 5 and less than or equal to 10---1.0
- greater than 10 less than or equal to 15---1.2
- greater than 15---1.5
- Steroids: Patients on steroids must be on a stable or decreasing dose of steroids for greater than or equal to 1 week prior to study entry.
- Informed consent: All patients or their legal guardians (if the patient is less than 18 years old) or DPA must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study. When appropriate, pediatric patients will be included in all discussions in order to obtain verbal assent.
- Durable Power of Attorney (DPA): Assignment of DPA to a family member or guardian should be offered to all patients 18 to 21 years of age.
Who cannot join
- Patients with known or suspected neurofibromatosis-1
- Patients who have received prior chemotherapy, including radiosensitizers, or who are currently receiving other investigational chemotherapeutic agents
- Patients with a known hypersensitivity to interferon-alpha
- Pregnant or breast-feeding females are excluded because the effects of pegylated interferon alfa-2b (PEG-Intron (TM)) on the unborn fetus are unknown.
- Patients with clinically significant unrelated systemic illness (including autoimmune disease, serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal or Associate Investigators would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Study of Pegylated Interferon Alfa-2b (Peg-Intron (TM)) in Children With Diffuse Pontine Gliomas
Diffuse pontine gliomas are tumors on the pons portion of the brainstem. Their peak incidence is in children between 5 and 10 years old. Their location makes surgical resection impossible. Most patients are treated with radiation, which typically delays progression of the tumor for a median time of only about 6 months; median survival time is less than 1 year. The addition of chemotherapy has not improved the outcome.
Alpha, beta, and gamma interferons have been used to treat malignant brain tumors, with mixed results. Different doses and different methods of administration have been studied. Alpha interferon is usually given in high doses 2 or 3 times a week, but it has serious side effects at these doses. Recent studies have shown that administering chemotherapy more frequently at smaller doses (metronomic) may have a better effect against the tumor.
Read more
PEG-Intron(Trademark) is a form of interferon alpha combined with monomethoxy polyethylene glycol (PEG). It has a longer half-life than interferon alone, is administered once a week, and the long half-life reduces the peaks and troughs in blood levels.
This study will enroll 32 patients under age 21. The primary goals of the study are to determine if there is a difference in the 2-year survival rate of patients treated with radiation alone and those treated with radiation followed by PEG-Intron(Trademark) and to define the toxicities of PEG-Intron(Trademark) in the study doses. Secondary goals are to evaluate various magnetic resonance imaging (MRI) techniques for noninvasive monitoring of changes in the brainstem and to evaluate neuropsychological function.
In this study, PEG-Intron(Trademark) will be administered subcutaneously once a week at low doses (0.3 microgram per kilogram of body weight) for a 4-week cycle. The cycles will be repeated indefinitely until progression of disease or serious side effects develop. For less severe effects, the dose will be lowered and the patient may remain in the study. For more severe effects, the dose will be discontinued. Patients in the study may receive supportive medication but may not receive other forms of chemotherapy.
Patients or their caregivers will be instructed in how to inject the drug. Patients and/or caregivers will be asked to maintain a diary documenting the dose, site of administration, and any side effects. The diary will be reviewed at each National Cancer Institute (NCI) visit. Patients will return to NCI before cycles 2 and 3. If there are no significant side effects, patients may then return to NCI before every other cycle, indefinitely (i.e., before cycles 5, 7, 9, etc.).
Patients will undergo the following tests and procedures:
- Physical examination, including neurologic exam, monthly
- Complete blood count, differential, and platelet count weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
- Blood chemistries weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
- Endocrine function tests before each cycle
- Urinalysis before each cycle
- MRI of the brain before cycles 1, 2, 3, 5, 7, and every other month; patients may also have proton magnetic spectroscopic imaging performed at the time of the MRI
Read the detailed description
Background:
Children with diffuse pontine gliomas have a dismal prognosis. Because surgery in this area is difficult, radiation therapy has been the mainstay of treatment. Although some children may improve clinically after radiation therapy, the effect is short-lived and almost all progress within several months. Chemotherapy has not had a significant impact on survival. Interferon-alpha is a cytokine that has been studied in patients with gliomas and has demonstrated some activity in prior clinical trials.
Objectives:
- To compare the 2-year survival of pediatric patients with diffuse pontine gliomas receiving weekly subcutaneous low-dose pegylated interferon alfa-2b (PEG-Intron[TM]) injections after standard radiation therapy versus historical controls who have received radiation therapy alone.
- To define the toxicities of weekly low-dose pegylated interferon alfa-2b (PEG-Intron(Trademark)) in pediatric patients.
Eligibility:
Age: Patients must be less than or equal to 21 years of age.
Histological Diagnosis: Histologic confirmation is not required for this study. Patients must have a diffuse pontine glioma as diagnosed by MRI criteria below.
Radiologic Appearance: Patients must have a diffuse intrinsic tumor with the epicenter presumed to be in the pons. The T-2 weighted sequence must reveal a diffuse signal abnormality involving at least 50 percent of the pons.
Prior Therapy: The patient must have received adequate radiation therapy. Radiation must be completed between 2-10 weeks prior to the start of treatment with Peg-Intron[TM].
Design:
In this study, we plan to administer pegylated interferon alfa-2b (PEG-Intron[TM]) subcutaneously once a week to pediatric patients with diffuse pontine gliomas who have completed radiation therapy. The endpoint of the trial will be 2-year survival compared to historical controls.
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Being tested
- adjuvant therapy, pegylated interferon alfa
- Keywords
- Brainstem Glioma, Pediatric, Interferon, MR Imaging, Angiogenesis, Brain Tumor, Glioma, Pediatric Brain Tumor
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant therapyProcedure or surgery
pegylated interferon alfaBiological
0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
| Study group | Role | What they receive |
|---|---|---|
| Interferon Alfa | Experimental | 0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria. Receives: Procedure: adjuvant therapy; Biological: pegylated interferon alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas
Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.
Measured: 8 yrs 6 mo 0 days
Secondary outcomes (4)
Median Time to Progression
Time between the final day of treatment to the day of disease progression.
Measured: 8 yrs 11 mo 22 days
Number of Participants With Adverse Events
Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Measured: 8 yrs 11 mo 22 days
Mean Quality of Life (QOL) Score at Baseline and Follow-Up
QOL questionnaires will be performed prior to every cycle for patients age 6-18 years and their parents until cycle 27 and then prior to every third cycle until cycle 52 when the evaluations will become annual. The QOL (NIH Impact of Pediatric Illness Scale) is too detailed to be described and/or shown here. It is a questionnaire made up of approximately 40 questions-the answers are ranked from 1 to 5 with 5 being no impact and 1 being significant impact-For further details see the protocol.
Measured: once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques
MRI of the brain will be performed at the NCI prior to cycles 1, 2, 3, 5, 7, and continuing every other month until cycle 27. Following cycle 27 the patient will have an MRI performed every third cycle until cycle 52 at which time they will have an MRI performed annually, and when clinically indicated. Baseline MR images are compared with MR images performed during the various cycles (e.g. cycles 1, 2, 3...) Imaging was exploratory and the degree of change that is considered clinically significant rather than technique related is still being explored.
Measured: once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2002 (estimated)
- Study startMay 2002
- Primary completionDec 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diffuse Intrinsic Pontine GliomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kathy Warren, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036569
- Sponsor's protocol ID
- 020193
- Other IDs
- 02-C-0193
- Status last verified
- Jan 2012
- First submitted
- 10 May 2002
- Last updated
- 13 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Packer RJ, Nicholson HS, Vezina LG, Johnson DL. Brainstem gliomas. Neurosurg Clin N Am. 1992 Oct;3(4):863-79.
PubMed 1392581Freeman CR, Farmer JP. Pediatric brain stem gliomas: a review. Int J Radiat Oncol Biol Phys. 1998 Jan 15;40(2):265-71. doi: 10.1016/s0360-3016(97)00572-5.
PubMed 9457808Barkovich AJ, Krischer J, Kun LE, Packer R, Zimmerman RA, Freeman CR, Wara WM, Albright L, Allen JC, Hoffman HJ. Brain stem gliomas: a classification system based on magnetic resonance imaging. Pediatr Neurosurg. 1990-1991;16(2):73-83. doi: 10.1159/000120511.
PubMed 2132928
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pegylated Interferon Alfa-2b (Peg-Intron (TM)) in Children With Diffuse Pontine Gliomas
- ClinicalTrials.gov ID
- NCT00036569
- Acronym / sponsor ID
- 020193
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Keywords
- Brainstem Glioma, Pediatric, Interferon, MR Imaging, Angiogenesis, Brain Tumor, Glioma, Pediatric Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2002
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 May 2002 (estimated)
- Results
- Posted 13 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diffuse pontine gliomas are tumors on the pons portion of the brainstem. Their peak incidence is in children between 5 and 10 years old. Their location makes surgical resection impossible. Most patients are treated with radiation, which typically delays progression of the tumor for a median time of only about 6 months; median survival time is less than 1 year. The addition of chemotherapy has not improved the outcome.
Alpha, beta, and gamma interferons have been used to treat malignant brain tumors, with mixed results. Different doses and different methods of administration have been studied. Alpha interferon is usually given in high doses 2 or 3 times a week, but it has serious side effects at these doses. Recent studies have shown that administering chemotherapy more frequently at smaller doses (metronomic) may have a better effect against the tumor.
PEG-Intron(Trademark) is a form of interferon alpha combined with monomethoxy polyethylene glycol (PEG). It has a longer half-life than interferon alone, is administered once a week, and the long half-life reduces the peaks and troughs in blood levels.
This study will enroll 32 patients under age 21. The primary goals of the study are to determine if there is a difference in the 2-year survival rate of patients treated with radiation alone and those treated with radiation followed by PEG-Intron(Trademark) and to define the toxicities of PEG-Intron(Trademark) in the study doses. Secondary goals are to evaluate various magnetic resonance imaging (MRI) techniques for noninvasive monitoring of changes in the brainstem and to evaluate neuropsychological function.
In this study, PEG-Intron(Trademark) will be administered subcutaneously once a week at low doses (0.3 microgram per kilogram of body weight) for a 4-week cycle. The cycles will be repeated indefinitely until progression of disease or serious side effects develop. For less severe effects, the dose will be lowered and the patient may remain in the study. For more severe effects, the dose will be discontinued. Patients in the study may receive supportive medication but may not receive other forms of chemotherapy.
Patients or their caregivers will be instructed in how to inject the drug. Patients and/or caregivers will be asked to maintain a diary documenting the dose, site of administration, and any side effects. The diary will be reviewed at each National Cancer Institute (NCI) visit. Patients will return to NCI before cycles 2 and 3. If there are no significant side effects, patients may then return to NCI before every other cycle, indefinitely (i.e., before cycles 5, 7, 9, etc.).
Patients will undergo the following tests and procedures:
- Physical examination, including neurologic exam, monthly
- Complete blood count, differential, and platelet count weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
- Blood chemistries weekly during cycle 1 and every 2 weeks thereafter if no severe side effects occur
- Endocrine function tests before each cycle
- Urinalysis before each cycle
- MRI of the brain before cycles 1, 2, 3, 5, 7, and every other month; patients may also have proton magnetic spectroscopic imaging performed at the time of the MRI
Detailed description
Background:
Children with diffuse pontine gliomas have a dismal prognosis. Because surgery in this area is difficult, radiation therapy has been the mainstay of treatment. Although some children may improve clinically after radiation therapy, the effect is short-lived and almost all progress within several months. Chemotherapy has not had a significant impact on survival. Interferon-alpha is a cytokine that has been studied in patients with gliomas and has demonstrated some activity in prior clinical trials.
Objectives:
- To compare the 2-year survival of pediatric patients with diffuse pontine gliomas receiving weekly subcutaneous low-dose pegylated interferon alfa-2b (PEG-Intron[TM]) injections after standard radiation therapy versus historical controls who have received radiation therapy alone.
- To define the toxicities of weekly low-dose pegylated interferon alfa-2b (PEG-Intron(Trademark)) in pediatric patients.
Eligibility:
Age: Patients must be less than or equal to 21 years of age.
Histological Diagnosis: Histologic confirmation is not required for this study. Patients must have a diffuse pontine glioma as diagnosed by MRI criteria below.
Radiologic Appearance: Patients must have a diffuse intrinsic tumor with the epicenter presumed to be in the pons. The T-2 weighted sequence must reveal a diffuse signal abnormality involving at least 50 percent of the pons.
Prior Therapy: The patient must have received adequate radiation therapy. Radiation must be completed between 2-10 weeks prior to the start of treatment with Peg-Intron[TM].
Design:
In this study, we plan to administer pegylated interferon alfa-2b (PEG-Intron[TM]) subcutaneously once a week to pediatric patients with diffuse pontine gliomas who have completed radiation therapy. The endpoint of the trial will be 2-year survival compared to historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interferon Alfa | Experimental | Procedure: adjuvant therapy, Biological: pegylated interferon alfa0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (23 listed)
- Age: Patients must be less than or equal to 21 years of age.
- Histological diagnosis: Histologic confirmation is not required for this study. Patients must have a diffuse pontine glioma as diagnosed by magnetic resonance imaging (MRI) criteria below.
- Radiographic Appearance: Patients must have a diffuse intrinsic tumor with the epicenter presumed to be in the pons. The T-2 weighted sequence must reveal a diffuse signal abnormality involving at least 50 percent of the pons.
- Prior therapy: The patient must have received adequate radiation therapy. (Radiation must be completed between 2-10 weeks prior to the start of treatment with Peg-Intron (TM).
- Performance status: Patients should have an Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 (see below). Patients who are unable to walk because of paralysis, but who are up in a wheel chair will be considered ambulatory for the purpose of calculating the performance score.
Key exclusion criteria (5 listed)
- Patients with known or suspected neurofibromatosis-1
- Patients who have received prior chemotherapy, including radiosensitizers, or who are currently receiving other investigational chemotherapeutic agents
- Patients with a known hypersensitivity to interferon-alpha
- Pregnant or breast-feeding females are excluded because the effects of pegylated interferon alfa-2b (PEG-Intron (TM)) on the unborn fetus are unknown.
- Patients with clinically significant unrelated systemic illness (including autoimmune disease, serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal or Associate Investigators would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results.
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 |
|---|---|---|
| adjuvant therapy | Procedure or surgery | Interferon Alfa |
| pegylated interferon alfa0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria. | Biological | Interferon Alfa |
Primary outcome
Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas
Time frame: 8 yrs 6 mo 0 days
Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.
4 secondary outcomes
Median Time to Progression
Time frame: 8 yrs 11 mo 22 days
Number of Participants With Adverse Events
Time frame: 8 yrs 11 mo 22 days
Mean Quality of Life (QOL) Score at Baseline and Follow-Up
Time frame: once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques
Time frame: once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1392581Packer RJ, Nicholson HS, Vezina LG, Johnson DL. Brainstem gliomas. Neurosurg Clin N Am. 1992 Oct;3(4):863-79.
- Background: PubMed 9457808Freeman CR, Farmer JP. Pediatric brain stem gliomas: a review. Int J Radiat Oncol Biol Phys. 1998 Jan 15;40(2):265-71. doi: 10.1016/s0360-3016(97)00572-5.
- Background: PubMed 2132928Barkovich AJ, Krischer J, Kun LE, Packer R, Zimmerman RA, Freeman CR, Wara WM, Albright L, Allen JC, Hoffman HJ. Brain stem gliomas: a classification system based on magnetic resonance imaging. Pediatr Neurosurg. 1990-1991;16(2):73-83. doi: 10.1159/000120511.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Medline PlusLink provided by the sponsor.
- Drug informationLink provided by the sponsor.
- United States FDA ResourcesLink provided by the sponsor.
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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.
Kathy Warren, M.D. principal investigator
National Cancer Institute (NCI)
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 adjuvant therapy and pegylated interferon alfa in people with Diffuse Intrinsic Pontine Glioma, 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 23 inclusion and 5 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 13 Feb 2012. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas (time frame: 8 yrs 6 mo 0 days). 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 NCT00036569, which also lists 3 linked publications.
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 13 Feb 2012; AzTrials last refreshed its copy on 6 Nov 2026.