Trial record 6 of 507 for:    Chlormethine

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
  Purpose

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.


Condition Intervention Phase
Hodgkin's Lymphoma
Drug: Adriamycin, Vinblastine, Vincristine, Bleomycin, Etoposide, Nitrogen Mustard (Cyclophosphamide), Prednisone
Procedure: Radiotherapy
Drug: Etoposide, Nitrogen Mustard (Cyclophosphamide) , Vincristine, Vinblastine, Adriamycin, Bleomycin, Prednisone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 82
Study Start Date: July 2006
Estimated Study Completion Date: November 2022
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352027

Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Maine
Maine Children's Medical Center
Portland, Maine, United States, 04102-3175
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Monika Metzger, M.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00352027     History of Changes
Other Study ID Numbers: HOD05
Study First Received: July 13, 2006
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Hodgkin's Disease

Additional relevant MeSH terms:
Mechlorethamine
Nitrogen Mustard Compounds
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Liposomal doxorubicin
Etoposide phosphate
Cyclophosphamide
Etoposide
Prednisone
Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014