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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications