DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Information source: St. Jude Children's Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin's Lymphoma

Intervention: Adriamycin, Vinblastine, Vincristine, Bleomycin, Etoposide, Nitrogen Mustard (Cyclophosphamide), Prednisone (Drug); Radiotherapy (Procedure); Etoposide, Nitrogen Mustard (Cyclophosphamide) , Vincristine, Vinblastine, Adriamycin, Bleomycin, Prednisone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: St. Jude Children's Research Hospital

Official(s) and/or principal investigator(s):
Monika Metzger, M.D., Principal Investigator, Affiliation: St. Jude Children's Research Hospital

Summary

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.

Clinical Details

Official title: Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event free survival

Secondary outcome:

Disease failure rate within radiation fields

Treatment failure patterns for children treated with tailored-field radiation

Prognostic factors for treatment failure

Describe toxicities, particularly the frequency and severity of late effects of therapy

Patient quality of life (QoL)

Parent proxy quality of life (QoL)

Correlation of agreement between patient QoL and parent proxy QoL at multiple time points

Symptom distress

Correlation between QoL and symptom distress

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

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

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

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.

Locations and Contacts

Stanford University Medical Center, Palo Alto, California 94304, United States

Rady Children's Hospital San Diego, San Diego, California 92123, United States

Maine Children's Medical Center, Portland, Maine 04102-3175, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Additional Information

St. Jude Children's Research Hospital

Clinical Trials Open at St. Jude

Starting date: July 2006
Last updated: June 11, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017