TriangleNCT00070473 · CITED IN SOURCE DOCUMENTS
Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1
- Status at capture
- COMPLETED
- Registry last update
- 2014-02-20
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- maximum Age
- 21 Years
- minimum Age
- 1 Year
- sex
- ALL
- std Ages
- CHILD
- ADULT
Treatment arms and interventions
- interventions
- name
- pemetrexed disodium
- type
- DRUG
Study design
- primary Purpose
- TREATMENT
Enrollment
- count
- 33
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Event Free Survival
- time Frame
- Length of study
- secondary Outcomes
- description
- 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.
- measure
- Dose Limiting Toxicity
- time Frame
- Length of study
- description
- The MTD will be that dose at which fewer than one-third of patients experience DLT
- measure
- Maximum Tolerated Dose
- time Frame
- Length of study
Full study description
- 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.
- 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.
Source references
- references
- citation
- 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.
- pmid
- 17442992
- type
- RESULT
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