Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00070473
Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
A Phase 1 study testing pemetrexed disodium in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 20 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium 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 1 year to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- pemetrexed disodium
- How many people
- 33 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Oct 2003to Jun 2008
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor for which there is no known curative therapy or therapy that is known to prolong survival with acceptable quality of life
- Histologic requirement waived for intrinsic brain stem tumors
- No pleural effusion or ascites
- Neurological deficits from CNS tumors must have been relatively stable for at least 1 week prior to study entry
PATIENT CHARACTERISTICS:
Age
- 1 to 21
Performance status
- Karnofsky 50-100% (over 10 years of age)
- Lansky 50-100% (10 years of age and under)
Life expectancy
- At least 8 weeks
Hematopoietic
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3 (transfusion independent)
- Hemoglobin at least 8.0 g/dL (transfusion allowed)
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 2.5 times ULN
- Albumin at least 2 g/dL
Renal
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR
- Creatinine based on age as follows:
- No greater than 0.8 mg/dL (age 5 and under)
- No greater than 1.0 mg/dL (age 6 to 10)
- No greater than 1.2 mg/dL (age 11 to 15)
- No greater than 1.5 mg/dL (age 16 and over)
Pulmonary
- No evidence of dyspnea at rest
- No exercise intolerance
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of Approved-not yet active graft-versus-host disease
- No uncontrolled infection
- Seizure disorder allowed provided it is well-controlled with anticonvulsants
- CNS toxicity no greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Recovered from prior immunotherapy
- At least 7 days since prior antineoplastic biologic therapy
- At least 6 months since prior allogeneic stem cell transplantation
- More than 1 week since prior growth factors
- No concurrent biologic therapy
- No concurrent immunotherapy
- No concurrent prophylactic growth factor support during course 1
Chemotherapy
- No prior pemetrexed disodium
- More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No other concurrent chemotherapy
Endocrine therapy
- Concurrent dexamethasone for CNS tumors allowed provided dose has been stable or decreasing for at least 1 week prior to study entry
Radiotherapy
- Recovered from all prior radiotherapy
- At least 2 weeks since prior local palliative radiotherapy
- At least 6 months since prior craniospinal radiotherapy
- At least 6 months since prior radiotherapy to 50% or more of the pelvis
- At least 6 weeks since prior substantial bone marrow radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No trimethoprim or sulfa within 2 days before and after study drug administration
- No concurrent nonsteroidal anti-inflammatory agents (e.g., ibuprofen and aspirin)
- No other concurrent anticancer or investigational agents
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States18 sites
NCI - Pediatric Oncology Branch
Bethesda, Maryland, 301496
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Baylor University Medical Center - Houston
Houston, Texas, 832822
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Children's Hospital Los Angeles
Los Angeles, California, 323669
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, 55455
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 215590
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 206987
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Canada2 sites
Hopital Sainte Justine
Montreal, Quebec
Hospital for Sick Children
Toronto, Ontario
About this study
Official title: A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed disodium in treating young patients with recurrent solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of pemetrexed disodium in children and adolescents with refractory solid tumors.
- Determine the dose-limiting toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine, preliminarily, the antitumor activity of this drug in these patients.
- Correlate the presence of the C677T polymorphism of the methylenetetrahydrolate reductase gene, the presence of a polymorphism in the enhancer region of the thymidylate synthase (TS) gene promoter (2R and 3R tandem repeats), the presence of a polymorphism within one of those repeats, and the presence of a functional polymorphism in the 3'-untranslated region with toxicity in patients treated with this drug.
- Correlate homocysteine and methylmalonic acid levels at study entry with toxicity in patients treated with this drug.
- Correlate various gene expression profiles with response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium 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.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1 year.
- Being tested
- pemetrexed disodium
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed disodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Measured: Length of study
Secondary outcomes (2)
Dose Limiting Toxicity
Any patient who experiences DLT at any time during protocol therapy will be considered evaluable for toxicity. Patients not experiencing DLT must complete a full cycle of therapy to be considered potentially evaluable for toxicity. Patients who are not evaluable for toxicity will be replaced.
Measured: Length of study
Maximum Tolerated Dose
The MTD will be that dose at which fewer than one-third of patients experience DLT
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startOct 2003
- Primary completionMar 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- H. Stacy Nicholson, MD, MPH, Study chair, OHSU Knight Cancer InstituteLinda C. Stork, MD, Study chair, Doernbecher Children's Hospital at Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070473
- Sponsor's protocol ID
- ADVL0311
- Other IDs
- NCI-04-C-0261, CDR0000334572, COG-ADVL0311
- Status last verified
- Feb 2014
- First submitted
- 3 Oct 2003
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malempati S, Nicholson HS, Reid JM, Blaney SM, Ingle AM, Krailo M, Stork LC, Melemed AS, McGovern R, Safgren S, Ames MM, Adamson PC; Children's Oncology Group. Phase I trial and pharmacokinetic study of pemetrexed in children with refractory solid tumors: the Children's Oncology Group. J Clin Oncol. 2007 Apr 20;25(12):1505-11. doi: 10.1200/JCO.2006.09.1694.
PubMed 17442992
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT00070473
- Acronym / sponsor ID
- ADVL0311
- Keywords
- unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Oct 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.
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed disodium in treating young patients with recurrent solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of pemetrexed disodium in children and adolescents with refractory solid tumors.
- Determine the dose-limiting toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine, preliminarily, the antitumor activity of this drug in these patients.
- Correlate the presence of the C677T polymorphism of the methylenetetrahydrolate reductase gene, the presence of a polymorphism in the enhancer region of the thymidylate synthase (TS) gene promoter (2R and 3R tandem repeats), the presence of a polymorphism within one of those repeats, and the presence of a functional polymorphism in the 3'-untranslated region with toxicity in patients treated with this drug.
- Correlate homocysteine and methylmalonic acid levels at study entry with toxicity in patients treated with this drug.
- Correlate various gene expression profiles with response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium 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.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| pemetrexed disodium | Drug | – |
Primary outcome
Event Free Survival
Time frame: Length of study
2 secondary outcomes
Dose Limiting Toxicity
Time frame: Length of study
Maximum Tolerated Dose
Time frame: Length of study
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 20 Feb 2014.
- Results publication: PubMed 17442992Malempati S, Nicholson HS, Reid JM, Blaney SM, Ingle AM, Krailo M, Stork LC, Melemed AS, McGovern R, Safgren S, Ames MM, Adamson PC; Children's Oncology Group. Phase I trial and pharmacokinetic study of pemetrexed in children with refractory solid tumors: the Children's Oncology Group. J Clin Oncol. 2007 Apr 20;25(12):1505-11. doi: 10.1200/JCO.2006.09.1694.
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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.
H. Stacy Nicholson, MD, MPH study chair
OHSU Knight Cancer Institute
Linda C. Stork, MD study chair
Doernbecher Children's Hospital at Oregon Health and Science University
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pemetrexed disodium in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada. 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?
Event Free Survival (time frame: Length of study). 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 NCT00070473, which also lists 1 linked publication.
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 20 Feb 2014.