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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00006095




Registration number
NCT00006095
Ethics application status
Date submitted
3/08/2000
Date registered
22/05/2003
Date last updated
21/02/2014

Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Scientific title
A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
Secondary ID [1] 0 0
COG-P9971
Secondary ID [2] 0 0
P9971
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - irinotecan hydrochloride
Treatment: Drugs - vincristine sulfate

Experimental: Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan -

Experimental: Vincristine sulfate 2.0 mg/m2/wk and Irinotecan -


Treatment: Drugs: irinotecan hydrochloride


Treatment: Drugs: vincristine sulfate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Length of study
Secondary outcome [1] 0 0
Toxicity
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
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
Minimum age
1 Year
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2005
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00006095
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cynthia S. Kretschmar, MD
Address 0 0
Floating Hospital for Children at Tufts - New England Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00006095