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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00070304




Registration number
NCT00070304
Ethics application status
Date submitted
3/10/2003
Date registered
7/10/2003
Date last updated
26/07/2013

Titles & IDs
Public title
Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma
Scientific title
A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease
Secondary ID [1] 0 0
CDR0000331915
Secondary ID [2] 0 0
AHOD0321
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 - gemcitabine hydrochloride
Treatment: Drugs - vinorelbine tartrate

Experimental: Treatment - Patients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell transplantation off study OR receive 2 additional courses. Patients with stable disease after 2 courses receive at least 2 additional courses. Patients with continued stable or responding disease (with no disease progression) after 4 courses may continue to receive study treatment for up to 1 year or discontinue study for alternative therapy at the discretion of the treating physician.


Treatment: Other: filgrastim
Given by mouth or IV, 5 micrograms/kg/dose (up to 10 micrograms/kg/dose) daily starting on day 9 for a minimum of 7 days and until the ANC is greater to or equal to 1,500/uL.

Treatment: Drugs: gemcitabine hydrochloride
Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8

Treatment: Drugs: vinorelbine tartrate
Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8
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
Tumor Response Rate
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [1] 0 0
Toxicities
Timepoint [1] 0 0
Up to 4 weeks following the completion of therapy

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed Hodgkin's lymphoma* with any of the following histologies:

* Not otherwise specified (NOS)
* Mixed cellularity NOS
* Lymphocytic depletion

* NOS
* Diffuse fibrosis
* Reticular
* Lymphocytic predominance

* NOS
* Diffuse
* Nodular
* Paragranuloma
* Granuloma
* Sarcoma
* Nodular sclerosis

* Cellular phase
* NOS
* Lymphocytic predominance
* Mixed cellularity
* Lymphocytic depletion NOTE: *Disease metastatic to bone marrow with granulocytopenia and/or thrombocytopenia is allowed, but is not evaluable for hematological toxicity
* Measurable disease by clinical or radiographic criteria
* Relapsed or refractory to conventional therapy

* Received at least 2 prior cytotoxic chemotherapy regimens
* No stage IA or IIA nodal disease previously treated with any of the following:

* Radiotherapy only
* No more than 4 courses of prior chemotherapy

PATIENT CHARACTERISTICS:

Age

* 30 and under

Performance status

* Karnofsky 50-100% (over 16 years of age)
* Lansky 50-100% (16 and under) OR
* ECOG 0-2

Life expectancy

* At least 8 weeks

Hematopoietic

* See Disease Characteristics
* Absolute neutrophil count = 750/mm^3
* Platelet count = 75,000/mm^3 (transfusion independent, defined as = 3 days since prior platelet transfusion)

Hepatic

* Bilirubin = 1.5 times upper limit of normal (ULN)
* ALT = 2.5 times ULN

Renal

* Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR
* Creatinine based on age as follows:

* No greater than 0.8 mg/dL (age 5 and under)
* No greater than 1.0 mg/dL (age 6 to 10)
* No greater than 1.2 mg/dL (age 11 to 15)
* No greater than 1.5 mg/dL (over age 15)

Pulmonary

* DLCO = 50%
* FEV_1 = 50%
* Vital capacity = 50%
* No evidence of dyspnea at rest
* No exercise intolerance

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* Seizure disorder allowed provided patient is on anticonvulsants and disorder is well controlled
* No evidence of active graft-versus-host disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Recovered from prior immunotherapy
* At least 6 months since prior allogeneic stem cell transplantation (SCT)
* At least 7 days since prior biologic agents
* More than 3 months since prior autologous SCT
* More than 1 week since prior growth factors
* No concurrent immunomodulating agents

Chemotherapy

* See Disease Characteristics
* More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No prior gemcitabine and vinorelbine in combination (i.e., administered within 1 week of each other)

* Prior gemcitabine or vinorelbine administered alone is allowed
* No other concurrent chemotherapy

Endocrine therapy

* No concurrent steroids, including corticosteroids as an antiemetic or for control of graft-versus-host disease

* Concurrent corticosteroids allowed only for the following indications:

* Adrenal crisis in patients with suppressed pituitary/adrenal response
* Noncardiogenic pulmonary edema
* Allergic reactions to amphotericin or transfusions treated with low-dose hydrocortisone (less than 100 mg/m^2)

Radiotherapy

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered

Surgery

* Not specified

Other

* Concurrent immunosuppressive drugs allowed
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
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
33
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
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Alabama
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Arkansas
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California
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Connecticut
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District of Columbia
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Kansas
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Kentucky
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Massachusetts
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New Mexico
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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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Santurce
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Switzerland
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Geneva

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 gemcitabine and vinorelbine, 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: This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.
Trial website
https://clinicaltrials.gov/study/NCT00070304
Trial related presentations / publications
Cole PD, McCarten KM, Drachtman RA, Alarcon Pd, Chen L, Trippett TM, Schwartz CL. Early [(1)(8)F]fluorodeoxyglucose positron emission tomography-based response evaluation after treatment with gemcitabine and vinorelbine for refractory Hodgkin disease: a children's oncology group report. Pediatr Hematol Oncol. 2010 Nov;27(8):650-7. doi: 10.3109/08880018.2010.504250.
Cole PD, Schwartz CL, Drachtman RA, de Alarcon PA, Chen L, Trippett TM. Phase II study of weekly gemcitabine and vinorelbine for children with recurrent or refractory Hodgkin's disease: a children's oncology group report. J Clin Oncol. 2009 Mar 20;27(9):1456-61. doi: 10.1200/JCO.2008.20.3778. Epub 2009 Feb 17.
Public notes

Contacts
Principal investigator
Name 0 0
Peter Cole, MD
Address 0 0
Rutgers Cancer Institute of New Jersey
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/NCT00070304