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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00005977




Registration number
NCT00005977
Ethics application status
Date submitted
5/07/2000
Date registered
21/05/2003
Date last updated
21/08/2013

Titles & IDs
Public title
Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
Scientific title
A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All
Secondary ID [1] 0 0
COG-9917
Secondary ID [2] 0 0
9917
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - dexamethasone
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - ifosfamide
Treatment: Drugs - leucovorin calcium
Treatment: Drugs - methotrexate
Treatment: Drugs - vincristine sulfate

Experimental: STAGE III NHL (Trt 1) - A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.
Treatment ABABA

Experimental: STAGE IV NHL, -CNS (Trt 2) - A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.
Treatment ABABAB

Experimental: STAGE IV, +CNS (Trt 3) - A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy.
Treatment ABCABAB

Experimental: B-ALL, -CNS (Trt 2) - A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.
Treatment ABABAB

Experimental: B-ALL, +CNS (Trt 3) - A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy.
Treatment ABCABAB


Other interventions: filgrastim
Given IV

Treatment: Drugs: cyclophosphamide
Given IV

Treatment: Drugs: cytarabine
Given IV

Treatment: Drugs: dexamethasone
Given IV

Treatment: Drugs: doxorubicin hydrochloride
Given IV

Treatment: Drugs: etoposide
Given IV

Treatment: Drugs: ifosfamide
Given IV

Treatment: Drugs: leucovorin calcium
Given IV

Treatment: Drugs: methotrexate
Given IV

Treatment: Drugs: vincristine sulfate
Given IV

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival - Assess the effect of high dose methotrexate in combination with standard treatment per the POG 9317 protocol on 1-year event-free survival (EFS), monitor and assess toxicity, and estimate the hospitalization costs for the treatment of toxicity related side effects.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- One of the following diagnoses:

- Histologically confirmed small noncleaved cell non-Hodgkin's lymphoma

- Stage III or IV

- Burkitt's or non-Burkitt's by the Working Formulation OR

- Burkitt's or Burkitt's-like by the REAL classification

- Histologically confirmed B-cell acute lymphocytic leukemia

- At least 25% blasts in bone marrow

- FAB L3 morphology

- FAB L1 morphology allowed if blasts show B-cell markers (CD19, 20, 22) and
surface immunoglobulin positivity

- Must be registered on POG-9900 in past 8 days

PATIENT CHARACTERISTICS:

Age:

- Under 22 at time of diagnosis

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Negative pregnancy test

- HIV positive allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- No concurrent use of dexamethasone as antiemetic

Radiotherapy:

- Not specified

Surgery:

- Prior surgery allowed

Other:

- No prior therapy except surgery
Minimum age
No limit
Maximum age
22 Years
Gender
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 3
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)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Kansas
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United States of America
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Mississippi
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United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
State/province [20] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
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United States of America
State/province [32] 0 0
Washington
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United States of America
State/province [33] 0 0
West Virginia
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United States of America
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Wisconsin
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Canada
State/province [35] 0 0
Alberta
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Canada
State/province [36] 0 0
Ontario
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Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Netherlands
State/province [38] 0 0
Groningen
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Puerto Rico
State/province [39] 0 0
Santurce
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Switzerland
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Bern
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Switzerland
State/province [41] 0 0
Geneva
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Switzerland
State/province [42] 0 0
Lausanne

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 cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
Trial website
https://clinicaltrials.gov/show/NCT00005977
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hazem H. Mahmoud, MD
Address 0 0
Carol G. Simon Cancer Center at Morristown Memorial Hospital
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