Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070473
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2003-10-03
Brief Title:
Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of Pemetrexed LY231514 Alimta in Children and Adolescents With Recurrent Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
PURPOSE This phase I trial is studying the side effects and best dose of pemetrexed disodium in treating young patients with recurrent solid tumors
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-04-C-0261 | OTHER | None | None |
| CDR0000334572 | OTHER | None | None |
| COG-ADVL0311 | OTHER | Childrens Oncology Group | None |