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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00006760




Registration number
NCT00006760
Ethics application status
Date submitted
6/12/2000
Date registered
27/01/2003
Date last updated
26/07/2013

Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma
Scientific title
A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease
Secondary ID [1] 0 0
CCG-A5981
Secondary ID [2] 0 0
AHOD00P1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - filgrastim
Treatment: Drugs - ifosfamide
Treatment: Drugs - vinorelbine tartrate

Experimental: Treatment (ifosfamide, vinorelbine, filgrastim) - Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.


Treatment: Other: filgrastim
subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.

Treatment: Drugs: ifosfamide
V over 24 hours on days 1-4

Treatment: Drugs: vinorelbine tartrate
IV over 6-10 minutes on days 1 and 5.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
After 2 cycles
Secondary outcome [1] 0 0
Rate of successful PBSC harvest during re-induction defined as the ability to harvest 5 x 10^6 CD34+ cells/kg
Timepoint [1] 0 0
After 2 cycles
Secondary outcome [2] 0 0
Biologic markers
Timepoint [2] 0 0
At enrollment and during/after therapy
Secondary outcome [3] 0 0
Cardiac, hepatic, renal, hematologic toxicity
Timepoint [3] 0 0
Within 1 month of completion of therapy
Secondary outcome [4] 0 0
Toxic death
Timepoint [4] 0 0
Within 1 month of Completion of therapy

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed refractory or relapsed Hodgkin's lymphoma

* Mixed cellularity, not otherwise specified (NOS)
* Lymphocytic depletion, NOS
* Lymphocytic depletion, diffuse fibrosis
* Lymphocytic depletion, reticular
* Lymphocytic predominance, NOS
* Lymphocytic predominance, diffuse
* Lymphocytic predominance, nodular
* Hodgkin's paragranuloma NOS
* Hodgkin's granuloma
* Hodgkin's sarcoma
* Nodular sclerosis, NOS
* Nodular sclerosis, cellular phase
* Nodular sclerosis, lymphocytic predominance
* Nodular sclerosis, mixed cellularity
* Nodular sclerosis, lymphocytic depletion
* Other (type not specified)
* In first relapse
* Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed
* Not enrolled on POG-9426 unless there is an extranodal site of recurrence

PATIENT CHARACTERISTICS:

Age:

* Under 30 at diagnosis

Performance status:

* Lansky 60-100% (for patients 16 years and under)
* Karnofsky 60-100% (for patients over 16 years)

Life expectancy:

* At least 2 months

Hematopoietic:

* See Disease Characteristics
* Absolute neutrophil count at least 1,000/mm^3
* Platelet count at least 75,000/mm^3 (transfusion independent)

Hepatic:

* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal

Renal:

* Creatinine no greater than 1.5 times normal
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular:

* Shortening fraction at least 27% by echocardiogram OR
* Ejection fraction at least 50% by gated radionuclide

Other:

* No other concurrent serious illness
* No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any other component of study drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunomodulating agents

Chemotherapy:

* At least 2 weeks since prior chemotherapy (3 weeks for nitrosoureas) and recovered
* No other concurrent anticancer chemotherapy

Endocrine therapy:

* No concurrent steroids
* No concurrent corticosteroids (e.g., dexamethasone)

Radiotherapy:

* Recovered from prior radiotherapy

Surgery:

* Not specified
Minimum age
No limit
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 2
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
1/05/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
6001 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Connecticut
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Delaware
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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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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Michigan
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New York
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North Carolina
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Ohio
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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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Nova Scotia
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Ontario
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Quebec
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Saskatchewan

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, such as ifosfamide and vinorelbine, work in 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 children who have refractory or relapsed Hodgkin's lymphoma.
Trial website
https://clinicaltrials.gov/study/NCT00006760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tanya Trippett, MD
Address 0 0
Memorial Sloan Kettering Cancer 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/study/NCT00006760