Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors
Verified date | February 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | June 2008 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | NCI - Pediatric Oncology Branch | Bethesda | Maryland |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Baylor University Medical Center - Houston | Houston | Texas |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Fairview University Medical Center - University Campus | Minneapolis | Minnesota |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Cancer Institute at Oregon Health and Science University | Portland | Oregon |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Stanford Cancer Center at Stanford University Medical Center | Stanford | California |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
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: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event Free Survival | Length of study | Yes | |
Secondary | 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. | Length of study | Yes |
Secondary | Maximum Tolerated Dose | The MTD will be that dose at which fewer than one-third of patients experience DLT | Length of study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT01164163 -
INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease
|
Phase 1 | |
Completed |
NCT00985868 -
AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors
|
Phase 1 | |
Terminated |
NCT00949117 -
Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
|
Phase 2 | |
Completed |
NCT00253474 -
PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
|
Phase 1 | |
Completed |
NCT00281944 -
Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT00084695 -
Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases
|
Phase 2 | |
Completed |
NCT00053963 -
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
|
Phase 1 | |
Completed |
NCT00003070 -
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
|
Phase 3 | |
Completed |
NCT00004212 -
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Completed |
NCT00016861 -
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
|
Phase 1 | |
Completed |
NCT00003754 -
Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers
|
Phase 2 | |
Completed |
NCT00004005 -
Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
|
Phase 2 | |
Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
Recruiting |
NCT00898794 -
Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer
|
N/A | |
Terminated |
NCT00429702 -
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
|
Phase 2 | |
Completed |
NCT00459238 -
Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
|
N/A | |
Completed |
NCT00387920 -
Sunitinib in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
Completed |
NCT00138216 -
Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
Terminated |
NCT00176540 -
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
|
N/A |