Clinical trial · Interventional
Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors
NCT00070473CI-TRIAL-00013806completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event Free Survival
- timeFrame
- Length of study
Secondary outcomes (2)
- measure
- Dose Limiting Toxicity
- timeFrame
- Length of study
- 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
- Maximum Tolerated Dose
- timeFrame
- Length of study
- description
- The MTD will be that dose at which fewer than one-third of patients experience DLT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMalempati 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