Trial record 1 of 1 for:    nct00352027
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Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00352027
First received: July 13, 2006
Last updated: June 19, 2014
Last verified: June 2014

July 13, 2006
June 19, 2014
July 2006
May 2015   (final data collection date for primary outcome measure)
Event free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
the time from treatment start to the time of the first failure (disease recurrence, second malignancy or death)
To determine the event free survival for patients treated with reduced chemotherapy and radiation
Complete list of historical versions of study NCT00352027 on ClinicalTrials.gov Archive Site
  • Disease failure rate within radiation fields [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
  • Treatment failure patterns for children treated with tailored-field radiation [ Time Frame: 3 years follow-up ] [ Designated as safety issue: No ]
    Descriptive statistics related to local/distant failure will be produced. The cumulative incidence of local failure will be estimated and effects of prognostic factors will be examined. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Relapse rate within the radiation fields will be estimated and confidence interval will also be calculated.
  • Prognostic factors for treatment failure [ Time Frame: 3 years follow-up ] [ Designated as safety issue: Yes ]
  • Describe toxicities, particularly the frequency and severity of late effects of therapy [ Time Frame: 1, 2, 5, and 10 years post therapy ] [ Designated as safety issue: No ]
  • Patient quality of life (QoL) [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning
  • Parent proxy quality of life (QoL) [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Parent's assessment of child's physical, emotional, social, and school functioning over multiple time points.
  • Correlation of agreement between patient QoL and parent proxy QoL at multiple time points [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Assess and compare the patient reported and parent proxy quality of life across multiple time points
  • Symptom distress [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    The patient's degree of discomfort from specific treatment-related symptoms i.e., nausea, sleep disturbances, appetite, etc. across multiple time points.
  • Correlation between QoL and symptom distress [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy ] [ Designated as safety issue: No ]
    Assess the relationship between quality of life and symptom distress across multiple time points
  • Comparison of the survival distributions and toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99 and other combined modality regimens [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Log-rank tests used to compare event-free survival and overall survival
To study the quality of life for these patients before during and after treatment
Not Provided
Not Provided
 
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Treatment Plan Description:

Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9

Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)

Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11

Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12

G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin's Lymphoma
  • Drug: Adriamycin, Vinblastine, Vincristine, Bleomycin, Etoposide, Nitrogen Mustard (Cyclophosphamide), Prednisone
    See Detailed Description section for details of treatment interventions.
  • Procedure: Radiotherapy
    See Detailed Description section for details of treatment interventions.
  • Drug: Etoposide, Nitrogen Mustard (Cyclophosphamide) , Vincristine, Vinblastine, Adriamycin, Bleomycin, Prednisone
    See Detailed Description section for details of treatment interventions.
Experimental: Treatment
Interventions:
  • Drug: Adriamycin, Vinblastine, Vincristine, Bleomycin, Etoposide, Nitrogen Mustard (Cyclophosphamide), Prednisone
  • Procedure: Radiotherapy
  • Drug: Etoposide, Nitrogen Mustard (Cyclophosphamide) , Vincristine, Vinblastine, Adriamycin, Bleomycin, Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
82
November 2022
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is less than or equal to 21 years of age
  • Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
  • Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion Criteria:

  • Patients with favorable risk features
  • Patients with unfavorable risk features
  • Patients who have received prior therapy for Hodgkin lymphoma.
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00352027
HOD05
Yes
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Monika Metzger, M.D. St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
June 2014

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