Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00006463
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
A Phase 1 study testing ECTEINASCIDIN 743 in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 47 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors. PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- ECTEINASCIDIN 743
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 47 sitesin 3 countries
- Study dates
- Oct 2000to Sep 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor at original diagnosis Refractory to standard treatment or no curative therapy available No CNS tumor No bone marrow metastases (for less heavily pretreated stratum only)
PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky 50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT no greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Creatine phosphokinase less than 2 times normal No uncontrolled infection Seizure disorder allowed if well controlled on anticonvulsants No CNS toxicity greater than grade II
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy and recovered At least 1 week since prior growth factor therapy At least 6 months since prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated stratum: No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis For less heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater No prior irradiation to greater than 50% of pelvis Recovered from toxic effects of prior radiotherapy Surgery: Not specified Other: No concurrent foods or medication that interferes with P-450 metabolism Anticonvulsants allowed
Trial locations and contacts
47 sites in 3 countries.
47 sites in 3 countries
United States42 sites
Mott Children's Hospital
Ann Arbor, Michigan, 48109
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
Children's Hospital of Michigan
Detroit, Michigan, 48201
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Columbia Presbyterian Hospital
New York, New York, 10032
Children's Hospital of Orange County
Orange, California, 92868
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Canada3 sites
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Australia2 sites
Royal Children's Hospital
Parkville, Victoria, 3052
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
- Being tested
- ECTEINASCIDIN 743
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECTEINASCIDIN 743Drug
Also called ET-743, NSC S648766, IND 50,286
| Study group | Role | What they receive |
|---|---|---|
| Therapy ECTEINASCIDIN 743 (1100 ug/m2 ) | Experimental | Not described Receives: Drug: ECTEINASCIDIN 743 |
| ECTEINASCIDIN 743 (1300 ug/m2) | Experimental | Not described Receives: Drug: ECTEINASCIDIN 743 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: Length of study
Secondary outcomes (5)
Dose Limiting Toxicity
To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.
Determine a safe and tolerable dose of vincristine, when administered with irinotecan
To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
Determine the pharmacokinetics of vincristine and irinotecan
To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
Measured: Length of study
Determine the incidence and severity of other toxicities
To determine the incidence and severity of other toxicities of this combination.
Measured: Length of study
Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine
To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2004 (estimated)
- Study startOct 2000
- Primary completionJan 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sylvain Baruchel, MD, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006463
- Sponsor's protocol ID
- P9972
- Other IDs
- COG-P9972, POG-P9972, CDR0000068273
- Status last verified
- Feb 2014
- First submitted
- 6 Nov 2000
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lau L, Supko JG, Blaney S, Hershon L, Seibel N, Krailo M, Qu W, Malkin D, Jimeno J, Bernstein M, Baruchel S. A phase I and pharmacokinetic study of ecteinascidin-743 (Yondelis) in children with refractory solid tumors. A Children's Oncology Group study. Clin Cancer Res. 2005 Jan 15;11(2 Pt 1):672-7.
PubMed 15701855
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00006463
- Acronym / sponsor ID
- P9972
- Keywords
- unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2000
- Primary completion
- Jan 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 26 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy ECTEINASCIDIN 743 (1100 ug/m2 ) | Experimental | Drug: ECTEINASCIDIN 743 |
| ECTEINASCIDIN 743 (1300 ug/m2) | Experimental | Drug: ECTEINASCIDIN 743 |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECTEINASCIDIN 743Also: ET-743, NSC S648766, IND 50,286 | Drug | ECTEINASCIDIN 743 (1300 ug/m2), Therapy ECTEINASCIDIN 743 (1100 ug/m2 ) |
Primary outcome
Progression Free Survival
Time frame: Length of study
5 secondary outcomes
Dose Limiting Toxicity
Determine a safe and tolerable dose of vincristine, when administered with irinotecan
Determine the pharmacokinetics of vincristine and irinotecan
Time frame: Length of study
Determine the incidence and severity of other toxicities
Time frame: Length of study
Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine
Time frame: Length of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
- Results publication: PubMed 15701855Lau L, Supko JG, Blaney S, Hershon L, Seibel N, Krailo M, Qu W, Malkin D, Jimeno J, Bernstein M, Baruchel S. A phase I and pharmacokinetic study of ecteinascidin-743 (Yondelis) in children with refractory solid tumors. A Children's Oncology Group study. Clin Cancer Res. 2005 Jan 15;11(2 Pt 1):672-7.
Related trials for Unspecified Childhood Solid Tumor, Protocol Specific
RecruitingObservational study
Collection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid Tumors
Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
RecruitingObservational study
Liquid Biopsies in Pediatric Solid Tumors
Pediatric Solid Tumor, Unspecified, Protocol Specific
RecruitingPhase 3
Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children
Pediatric Solid Tumor, Unspecified, Protocol Specific
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Baruchel, MD study chair
The Hospital for Sick Children
47 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ECTEINASCIDIN 743 in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 47 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Length of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.