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

February 20, 2014 updated by: Children's Oncology Group

A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors

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.

Study Overview

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Actual)

20

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

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

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 (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 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

Hematopoietic:

  • 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)

Hepatic:

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

Renal:

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

Other:

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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

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

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
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan
Other Names:
  • CPT-11
  • NSC #616348
Other Names:
  • VCR
  • Oncovin
  • NSC #067574
EXPERIMENTAL: Vincristine sulfate 2.0 mg/m2/wk and Irinotecan
Other Names:
  • CPT-11
  • NSC #616348
Other Names:
  • VCR
  • Oncovin
  • NSC #067574

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: Length of study
Length of study

Secondary Outcome Measures

Outcome Measure
Toxicity

Collaborators and Investigators

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

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

July 1, 2000

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

May 21, 2003

First Posted (ESTIMATE)

May 22, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

February 21, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • P9971
  • COG-P9971 (OTHER: Children's Oncology Group)
  • CCG-P9971 (OTHER: Children's Cancer Group)
  • POG-9971 (OTHER: Pediatric Oncology Group)
  • CDR0000068102 (OTHER: Clinical Trials.gov)

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 Unspecified Childhood Solid Tumor, Protocol Specific

Clinical Trials on irinotecan hydrochloride

3
Subscribe