Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors

NCT00070473 | Completed Phase 1 DMC

• 4 other identifiers: ADVL0311NCI-04-C-0261CDR0000334572COG-ADVL0311
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 20

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.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  Length of study

Secondary Outcomes (2)

• Dose Limiting Toxicity

  Length of study

• Maximum Tolerated Dose

  Length of study

Interventions

pemetrexed disodium DRUG

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (20)

Children's Hospital Los Angeles

Los Angeles, California, 323669, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

NCI - Pediatric Oncology Branch

Bethesda, Maryland, 301496, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Fairview University Medical Center - University Campus

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 215590, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 832822, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 206987, United States

Location

Hospital for Sick Children

Toronto, Ontario, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• H. Stacy Nicholson, MD, MPH

  OHSU Knight Cancer Institute

  STUDY CHAIR

• Linda C. Stork, MD

  Doernbecher Children's Hospital at Oregon Health and Science University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2003
• First Posted: October 7, 2003
• Study Start: October 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: June 1, 2008
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

CA (2); US (18)