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Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00008424
Collaborator
National Cancer Institute (NCI) (NIH)
7
Enrollment
51
Locations
71
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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 irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants.

Condition or Disease Intervention/Treatment Phase
  • Drug: irinotecan hydrochloride
 Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants.

  • Determine the dose-limiting toxicity of irinotecan in this patient population.

  • Evaluate the pharmacokinetic behavior of this treatment regimen in these patients.

  • Determine, preliminarily, the antitumor activity of this treatment regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants).

Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months for up to 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Primary Purpose:
Treatment
Official Title:
A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants
Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Sep 1, 2005
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerable dose (MTD) of irinotecan []

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy refractory to conventional therapy or for which no conventional therapy exists

  • Histologic confirmation not required for brain stem tumors

  • Concurrently on anticonvulsants at a steady level for at least 2 weeks

PATIENT CHARACTERISTICS:
Age:
  • 1-21 years old
Performance status:

  • Karnofsky 50-100% (over 10 years of age)

  • Lansky 50-100% (10 years of age or under)

Life expectancy:
  • At least 8 weeks
Hematopoietic:

  • Neutrophil count at least 1,000/mm3

  • Platelet count at least 100,000/mm3 (transfusion independent)

  • Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)

Hepatic:

  • Bilirubin no greater than 1.5 times normal for age

  • SGPT less than 5 times normal for age

  • Albumin at least 2 g/dL

Renal:

  • Creatinine no greater than 1.5 times normal for age OR

  • Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age

Other:

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • No uncontrolled infection

  • No evidence of active graft-vs-host disease

  • Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study

PRIOR CONCURRENT THERAPY:
Biologic therapy:

  • At least 1 week since prior antineoplastic biologic therapy

  • At least 6 months since prior allogeneic stem cell transplantation

  • At least 1 week since prior growth factors

  • No concurrent sargramostim (GM-CSF)

  • No concurrent prophylactic growth factors during first course of study therapy

  • Recovered from prior immunotherapy

Chemotherapy:
  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered
Endocrine therapy:
  • Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed if dose stable or decreasing for at least 2 weeks prior to study
Radiotherapy:

  • At least 2 weeks since prior local palliative radiotherapy (small part)

  • At least 6 months since prior craniospinal radiotherapy

  • At least 6 months since prior radiotherapy to at least 50% of pelvis

  • At least 6 weeks since prior substantial bone marrow radiotherapy

  • Recovered from prior radiotherapy

Surgery:
  • Not specified
Other:
  • No other concurrent investigational agent

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
2 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
3 University of California San Diego Cancer Center La Jolla California United States 92093-0658
4 Children's Hospital Los Angeles Los Angeles California United States 90027-0700
5 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
6 Children's Hospital of Orange County Orange California United States 92868
7 Lucile Packard Children's Hospital at Stanford Palo Alto California United States 94304
8 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
9 Children's Hospital of Denver Denver Colorado United States 80218
10 Children's National Medical Center Washington District of Columbia United States 20010-2970
11 Shands Hospital and Clinics, University of Florida Gainesville Florida United States 32610-100277
12 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
13 Children's Memorial Hospital, Chicago Chicago Illinois United States 60614
14 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
15 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
16 Boston Floating Hospital Infants and Children Boston Massachusetts United States 02111
17 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
18 Mott Children's Hospital Ann Arbor Michigan United States 48109-7821
19 Children's Hospital of Michigan Detroit Michigan United States 48201
20 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
21 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
22 Children's Mercy Hospital Kansas City Missouri United States 64108
23 Cardinal Glennon Children's Hospital Saint Louis Missouri United States 63104
24 Hackensack University Medical Center Hackensack New Jersey United States 07601
25 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
26 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
27 Columbia Presbyterian Hospital New York New York United States 10032
28 State University of New York - Upstate Medical University Syracuse New York United States 13210
29 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
30 Children's Hospital Medical Center - Cincinnati Cincinnati Ohio United States 45229-3039
31 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
32 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
33 Medical University of South Carolina Charleston South Carolina United States 29425-0721
34 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105-2794
35 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
36 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
37 Cook Children's Medical Center - Fort Worth Fort Worth Texas United States 76104
38 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
39 Baylor College of Medicine Houston Texas United States 77030
40 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
41 Huntsman Cancer Institute Salt Lake City Utah United States 84112
42 Children's Hospital and Regional Medical Center - Seattle Seattle Washington United States 98105
43 CCOP - Green Bay Green Bay Wisconsin United States 54301
44 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792-0001
45 Midwest Children's Cancer Center Milwaukee Wisconsin United States 53226
46 Women's and Children's Hospital North Adelaide South Australia Australia 5006
47 Royal Children's Hospital Parkville Victoria Australia 3052
48 Princess Margaret Hospital for Children Perth Western Australia Australia 6001
49 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
50 McGill University Health Center - Montreal Children's Hospital Montreal Quebec Canada H3H 1P3
51 Hopital Sainte Justine Montreal Quebec Canada H3T 1C5

Sponsors and Collaborators

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

Investigators

  • Study Chair: Albert Moghrabi, MD, Hopital Sainte Justine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00008424
Other Study ID Numbers:
  • P9871
  • COG-P9871
  • POG-P9871
  • CDR0000068410
First Posted:
Jun 5, 2003
Last Update Posted:
May 5, 2014
Last Verified:
May 1, 2014
Keywords provided by Children's Oncology Group
unspecified childhood solid tumor, protocol specific
Additional relevant MeSH terms:
Neoplasms
Irinotecan

Study Results

No Results Posted as of May 5, 2014