Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00006095
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
A Phase 1 study testing irinotecan hydrochloride and vincristine sulfate in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 22 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- irinotecan hydrochloride and vincristine sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Jul 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: 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.
Read the 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.
- Being tested
- irinotecan hydrochloride, vincristine sulfate
- 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.
Also called CPT-11, NSC #616348
Also called VCR, Oncovin, NSC #067574
| Study group | Role | What they receive |
|---|---|---|
| Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan | Experimental | Not described Receives: Drug: irinotecan hydrochloride; Drug: vincristine sulfate |
| Vincristine sulfate 2.0 mg/m2/wk and Irinotecan | Experimental | Not described Receives: Drug: irinotecan hydrochloride; Drug: vincristine sulfate |
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 (1)
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2003 (estimated)
- Study startJul 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.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cynthia S. Kretschmar, MD, Study chair, Floating Hospital for Children at Tufts - New England Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006095
- Sponsor's protocol ID
- P9971
- Other IDs
- COG-P9971, CCG-P9971, POG-9971, CDR0000068102
- Status last verified
- Feb 2014
- First submitted
- 3 Aug 2000
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
- ClinicalTrials.gov ID
- NCT00006095
- Acronym / sponsor ID
- P9971
- Keywords
- unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2000
- Primary completion
- Jan 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 22 May 2003 (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. 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan | Experimental | Drug: irinotecan hydrochloride, Drug: vincristine sulfate |
| Vincristine sulfate 2.0 mg/m2/wk and Irinotecan | Experimental | Drug: irinotecan hydrochloride, Drug: vincristine sulfate |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| irinotecan hydrochlorideAlso: CPT-11, NSC #616348 | Drug | Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan, Vincristine sulfate 2.0 mg/m2/wk and Irinotecan |
| vincristine sulfateAlso: VCR, Oncovin, NSC #067574 | Drug | Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan, Vincristine sulfate 2.0 mg/m2/wk and Irinotecan |
Primary outcome
Progression Free Survival
Time frame: Length of study
1 secondary outcome
Toxicity
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.
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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.
Cynthia S. Kretschmar, MD study chair
Floating Hospital for Children at Tufts - New England Medical Center
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing irinotecan hydrochloride and vincristine sulfate in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Children's Oncology Group at 22 sites in 2 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 22 sites in United States, 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?
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.