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

Primary Purpose

Brain and Central Nervous System Tumors, Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
liposomal cytarabine
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, unspecified childhood solid tumor, protocol specific, recurrent/refractory childhood Hodgkin lymphoma, leptomeningeal metastases, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • Stanford University Medical Center
  • University of Texas Southwestern Medical Center at Dallas
  • Texas Children's Cancer Center
  • Children's Hospital and Regional Medical Center - Seattle
  • Alberta Children's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 22, 2010
Sponsor
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00003073
Brief Title
Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
Official Title
A Phase I Dose Escalation Study of Intrathecal DepoFoam Encapsulated Cytarabine (DTC 101) in Pediatric Patients With Advanced Meningeal Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2002
Overall Recruitment Status
Unknown status
Study Start Date
February 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pacira Pharmaceuticals, Inc

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, unspecified childhood solid tumor, protocol specific, recurrent/refractory childhood Hodgkin lymphoma, leptomeningeal metastases, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
liposomal cytarabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E. Gait, MD
Organizational Affiliation
Pacira Pharmaceuticals, Inc
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-8897
Country
United States
Facility Name
Texas Children's Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada

12. IPD Sharing Statement

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

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