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Trial record 6 of 7 for:    stem cell kidney | ( Map: Switzerland )

Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070304
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date  ICMJE October 3, 2003
First Posted Date  ICMJE October 7, 2003
Last Update Posted Date July 26, 2013
Study Start Date  ICMJE July 2004
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
Tumor Response Rate [ Time Frame: Up to 1 year ]
Adequate tumor response is defined as achieving CR, VGPR or PR at any evaluation.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00070304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
Toxicities [ Time Frame: Up to 4 weeks following the completion of therapy ]
Toxic death, hepatic, cardiac or renal toxicity, hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma
Official Title  ICMJE A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease
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.

Detailed Description

OBJECTIVES:

  • Determine the response rate of pediatric patients with recurrent or refractory Hodgkin's lymphoma treated with gemcitabine and vinorelbine.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive vinorelbine IV over 6-10 minutes and gemcitabine 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.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: 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.
    Other Names:
    • Granulocyte Colony-Stimulating Factor
    • r-metHuG-CSF
    • G-CSF
    • Neupogen
    • NSC # 614629
  • Drug: gemcitabine hydrochloride
    Given IV over 100 minutes dose 1000 mg/m2/dose in 500 ml NS on days 1 and 8
    Other Names:
    • Gemzar
    • NSC #613327
  • Drug: vinorelbine tartrate
    Given IV over 6-10 minutes (central venous catheter). Dose 25 mg/m2/dose on days 1 and 8
    Other Names:
    • Navelbine
    • NSC #608210
Study Arms  ICMJE 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.
Interventions:
  • Biological: filgrastim
  • Drug: gemcitabine hydrochloride
  • Drug: vinorelbine tartrate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2013)
33
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland,   Australia,   Canada,   Puerto Rico,   United States
Removed Location Countries Netherlands,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT00070304
Other Study ID Numbers  ICMJE AHOD0321
CDR0000331915 ( Other Identifier: Clinical Trials.gov )
COG-AHOD0321 ( Other Identifier: Children's Oncology Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Peter Cole, MD Rutgers Cancer Institute of New Jersey
PRS Account Children's Oncology Group
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP