Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006095
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : February 21, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating children who have solid tumors that have not responded to previous therapy.

Condition or disease Intervention/treatment Phase
Unspecified Childhood Solid Tumor, Protocol Specific Drug: irinotecan hydrochloride Drug: vincristine sulfate Phase 1

Detailed Description:


  • Determine the maximum tolerated dose and dose limiting toxicity of vincristine when administered in combination with irinotecan in children with refractory solid tumors.
  • Determine the safe and tolerable phase II dose of this combination regimen in this patient population.
  • Determine the pharmacokinetics of this combination regimen in these patients.
  • Determine the incidence and severity of other toxicities of this combination regimen in these patients.
  • Determine preliminary evidence of antitumor activity of this combination regimen in this patient population.

OUTLINE: This is a dose-escalation study of vincristine.

Patients receive vincristine IV on day 2 of the first course (day 1 of subsequent courses) and days 8, 15, 22, and 29, and irinotecan IV over 1 hour on days 1-5 and 22-26. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease receive additional courses of therapy for a maximum of 1 year.

Cohorts of 3-6 patients receive escalating doses of vincristine 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 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
Study Start Date : July 2000
Actual Primary Completion Date : January 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan Drug: irinotecan hydrochloride
Other Names:
  • CPT-11
  • NSC #616348

Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC #067574

Experimental: Vincristine sulfate 2.0 mg/m2/wk and Irinotecan Drug: irinotecan hydrochloride
Other Names:
  • CPT-11
  • NSC #616348

Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC #067574

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Toxicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed initial diagnosis of malignant solid tumor refractory to conventional therapy or for which no effective therapy exists

    • Brain tumors allowed if not on anticonvulsants
    • Brainstem gliomas allowed without histologic diagnosis
    • Solid lymphomas allowed
  • No bone marrow involvement



  • 1 to 21

Performance status:

  • Karnofsky 50-100% if over 10 years of age
  • Lansky 50-100% if 10 years of age and under

Life expectancy:

  • At least 8 weeks


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8 g/dL (transfusion allowed)


  • Bilirubin no greater than 1.5 mg/dL
  • ALT less than 5 times normal
  • Albumin at least 2 g/dL


  • Creatinine normal for age OR
  • Glomerular filtration rate normal for age


  • No uncontrolled infection
  • No other significant systemic illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 1 week since prior biologic therapy and recovered
  • At least 1 week since prior growth factors
  • No prior stem cell transplantation


  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No more than 2 prior chemotherapy regimens
  • No other concurrent cancer chemotherapy

Endocrine therapy:

  • Concurrent dexamethasone allowed in patients with CNS tumors provided dose is stable or decreasing for at least 2 weeks prior to study


  • Recovered from prior radiotherapy
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • No prior substantial bone marrow radiotherapy
  • No prior central axis radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • No concurrent anticonvulsants
  • No other concurrent anticancer therapy or investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006095

United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital of Orange County
Orange, California, United States, 92868
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Cynthia S. Kretschmar, MD Floating Hospital for Children at Tufts - New England Medical Center

Responsible Party: Children's Oncology Group Identifier: NCT00006095     History of Changes
Other Study ID Numbers: P9971
COG-P9971 ( Other Identifier: Children's Oncology Group )
CCG-P9971 ( Other Identifier: Children's Cancer Group )
POG-9971 ( Other Identifier: Pediatric Oncology Group )
CDR0000068102 ( Other Identifier: Clinical )
First Posted: May 22, 2003    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014

Keywords provided by Children's Oncology Group:
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators