Recurrent Childhood Brain Stem GliomaPhase 1NCT00012181
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
A Phase 1 study testing alvocidib and pharmacological study in people with Recurrent Childhood Brain Stem Glioma and Recurrent Childhood Cerebellar Astrocytoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma
- What is being tested?
- alvocidib and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed relapsed or refractory solid tumor or lymphoma including:
- Neuroblastoma
- Osteosarcoma
- Ewing's sarcoma
- Rhabdomyosarcoma
- Wilms tumor
Show all 48Show fewer
- CNS tumors
- Histological verification not required for brainstem tumors
- No acute leukemia
- Not eligible for higher priority COG phase I/II study
- Performance status - Karnofsky 50-100% (over age 10)
- Performance status - Lansky 50-100% (age 10 and under)
- At least 2 months
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3 (transfusion independent)
- Hemoglobin at least 8.0 g/dL (transfusion allowed)
- No granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow involvement
- Bilirubin no greater than 1.5 times normal
- SGPT no greater than 5 times normal
- Albumin at least 2 g/dL
- Creatinine no greater than 1.5 times normal
- Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA
- Stable neurologic deficits within the past 2 weeks for patients with CNS tumors
- CNS toxicity less than grade 2
- No active graft-versus-host disease
- No active uncontrolled infection or other serious medical condition
- No uncontrolled diabetes mellitus
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- At least 7 days since prior biologic therapy and recovered
- Prior bone marrow or stem cell transplantation allowed
- At least 6 months since prior allogeneic stem cell transplantation
- 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 other concurrent chemotherapy
- Concurrent dexamethasone for CNS tumors allowed if on stable dose for at least 2 weeks prior to study
- Concurrent corticosteroids allowed only for increased intracranial pressure in patients with CNS tumors
- At least 2 weeks since prior local (small port) palliative radiotherapy
- At least 6 months since prior radiotherapy to 50% or more of the pelvis
- At least 6 months since prior craniospinal radiotherapy
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- Recovered from prior radiotherapy
- No concurrent radiotherapy except localized palliative radiotherapy
- No concurrent anticonvulsants
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 FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas.
II. Determine the toxic effects and pharmacokinetics of this drug in these patients.
III. Determine the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of flavopiridol 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.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 18 months.
- Conditions
- Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Liver Cancer
- Being tested
- alvocidib, pharmacological study
- Medical subject headings
- Astrocytoma, Familial ependymoma, Dendritic Cell Sarcoma, Interdigitating, Medulloblastoma, Burkitt Lymphoma, Optic Nerve Glioma, Neuroectodermal Tumors, Primitive, Peripheral, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alvocidibDrug
Also called FLAVO, flavopiridol, HMR 1275, L-868275
Given IV
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (alvocidib) | Experimental | Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: alvocidib; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2001
- Primary completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Childhood Brain Stem 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James Whitlock, Principal investigator, COG Phase I Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012181
- Sponsor's protocol ID
- NCI-2012-01854
- Other IDs
- ADVL0017, CCG-AO972, CDR0000068491, COG-ADVL0017, NCI-A0972, U01CA097452
- Status last verified
- Jul 2013
- First submitted
- 3 Mar 2001
- Last updated
- 2 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
- ClinicalTrials.gov ID
- NCT00012181
- Acronym / sponsor ID
- NCI-2012-01854
- Conditions
- Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- Jan 2005 (actual)
- First posted
- 27 Jan 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.
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.
Detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas.
II. Determine the toxic effects and pharmacokinetics of this drug in these patients.
III. Determine the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of flavopiridol 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.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (alvocidib) | Experimental | Drug: alvocidib, Other: pharmacological studyPatients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (48 listed)
- Histologically confirmed relapsed or refractory solid tumor or lymphoma including:
- Histological verification not required for brainstem tumors
- No acute leukemia
- Not eligible for higher priority COG phase I/II study
- Performance status - Karnofsky 50-100% (over age 10)
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 |
|---|---|---|
| alvocidibAlso: FLAVO, flavopiridol, HMR 1275, L-868275Given IV | Drug | Treatment (alvocidib) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (alvocidib) |
Primary outcome
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0
Time frame: Day 21
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 2 Jul 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.
James Whitlock 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 alvocidib and pharmacological study in people with Recurrent Childhood Brain Stem Glioma and Recurrent Childhood Cerebellar Astrocytoma, 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 48 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 2 Jul 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?
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0 (time frame: Day 21). 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 2 Jul 2013.