Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors

March 22, 2010 updated by: Pacira Pharmaceuticals, Inc

A Phase I Dose Escalation Study of Intrathecal DepoFoam Encapsulated Cytarabine (DTC 101) in Pediatric Patients With Advanced Meningeal Malignancies

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of liposomal cytarabine in treating young patients who have recurrent or refractory meningeal leukemia, lymphoma, or solid tumors.

Study Overview

Detailed Description

OBJECTIVES: I. Determine the qualitative or quantitative toxic effects and tolerability of liposomal cytarabine (Depofoam encapsulated cytarabine; DTC 101) in pediatric patients with recurrent or refractory meningeal malignancies. II. Define a safe dose of DTC 101 in these patients for future clinical studies. III. Determine the plasma and CSF pharmacokinetics of DTC 101 in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients are placed in one of three age-related strata: stratum 1, 3 to 21 years of age; stratum 2, at least 2 but less than 3 years of age; stratum 3, at least 1 but less than 2 years of age. Patients receive an induction dose of intrathecal liposomal cytarabine (Depofoam encapsulated cytarabine; DTC 101) administered once every 2 weeks for 2 courses. Patients who have achieved a partial response or received significant clinical benefit with stable disease may receive a third induction dose of DTC 101, 2 weeks following the second dose. In the absence of progressive disease, patients can proceed to consolidation therapy. During consolidation therapy, intrathecal DTC 101 is administered once every 4 weeks for 2 courses, beginning 4 weeks after the last induction dose. Patients experiencing a complete or significant response can proceed to maintenance therapy. Patients receive a maintenance dose of intrathecal DTC 101 once every 8 weeks for a total of 6 doses, beginning 4 weeks after the second consolidation dose. At least 3 patients are evaluated at each dose level. Dose escalation to the next level proceeds when a minimum of 3 patients per cohort has successfully completed induction therapy and been evaluated. Patients will be followed at 1, 2, 3, 6, 9, and 12 months post treatment, until relapse or death.

PROJECTED ACCRUAL: A minimum of 12-15 patients will be accrued for each stratum over 18 to 24 months.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
    • California
      • Los Angeles, California, United States, 90027-0700
        • Children's Hospital Los Angeles
      • Stanford, California, United States, 94305-5408
        • Stanford University Medical Center
    • Texas
      • Dallas, Texas, United States, 75235-8897
        • University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030-2399
        • Texas Children's Cancer Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center - Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory leukemia, lymphoma, or other solid tumor that has overt meningeal involvement Definition of meningeal disease: Leukemia/lymphoma: CSF cell count at least 5/mm3 and evidence of blast cells on cytospin preparation or cytology Solid tumors: Presence of tumor cells on cytospin preparation or cytology OR evidence of meningeal disease on CT or MRI scan No bone marrow disease

PATIENT CHARACTERISTICS: Age: 1 to 21 Performance Status: ECOG 0-2 Life Expectancy: At least 8 weeks Hematopoietic: Platelet count greater than 40,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL ALT less than 5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Effective contraceptive method used by fertile patients No uncontrolled illness or infection (except for HIV positive patients) No obstructive hydrocephalus or compartmentalization of the CSF flow

PRIOR CONCURRENT THERAPY: Biologic therapy: No acute toxic effects from prior immunotherapy No prior allogeneic or autologous bone marrow transplantations within 3 months of study Chemotherapy: No prior systemic CNS directed chemotherapy within 3 weeks of study No prior nitrosourea within 6 weeks of study No prior intrathecal chemotherapy within 1 week of study No acute toxic effects from prior chemotherapy No prior DTC 101 Concurrent systemic chemotherapy for management of primary cancer allowed Concurrent dexamethasone with systemic chemotherapy regimen allowed No concurrent chemotherapy for leptomeningeal disease No concurrent high dose methotrexate, high dose cytarabine, mercaptopurine, thiotepa, fluorouracil, and topotecan Endocrine therapy: Concurrent prednisone therapy with systemic chemotherapy allowed Radiotherapy: No prior craniospinal irradiation within 8 weeks of study No acute toxic effects from prior radiotherapy Concurrent local radiation therapy allowed No concurrent whole brain or craniospinal radiotherapy Surgery: Not specified Other: At least 2 weeks since investigational drugs and recovered No other concurrent investigational drugs Concurrent antibiotic therapy allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: John E. Gait, MD, Pacira Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

February 5, 2004

First Posted (Estimate)

February 6, 2004

Study Record Updates

Last Update Posted (Estimate)

March 23, 2010

Last Update Submitted That Met QC Criteria

March 22, 2010

Last Verified

April 1, 2002

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on liposomal cytarabine

Subscribe