NCT00006095

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_1

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

4.5 years

First QC Date

August 3, 2000

Last Update Submit

February 20, 2014

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Length of study

Secondary Outcomes (1)

  • Toxicity

Study Arms (2)

Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan

EXPERIMENTAL
Drug: irinotecan hydrochlorideDrug: vincristine sulfate

Vincristine sulfate 2.0 mg/m2/wk and Irinotecan

EXPERIMENTAL
Drug: irinotecan hydrochlorideDrug: vincristine sulfate

Interventions

irinotecan hydrochlorideDRUG
Also known as: CPT-11, NSC #616348
Vincristine Sulfate 1.5 mg/m2/wk and IrinotecanVincristine sulfate 2.0 mg/m2/wk and Irinotecan
vincristine sulfateDRUG
Also known as: VCR, Oncovin, NSC #067574
Vincristine Sulfate 1.5 mg/m2/wk and IrinotecanVincristine sulfate 2.0 mg/m2/wk and Irinotecan

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (22)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

MeSH Terms

Interventions

IrinotecanVincristine

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Cynthia S. Kretschmar, MD

    Floating Hospital for Children at Tufts - New England Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

May 22, 2003

Study Start

July 1, 2000

Primary Completion

January 1, 2005

Study Completion

September 1, 2005

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

AU(1)US(21)