Reduced Duration Standford V Chemotherapy With Low-Dose Tailored-Field Radiation For Favorable Risk Pediatric Hodgkin Lymphoma - Full Text View

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00846742

Purpose

This is a phase II clinical trial using risk-adapted, multi-modality therapy. The goals of this study are to 1) Increase the proportion of patients that will be in complete remission at the end of 8 weeks of chemotherapy and therefore will not require radiation therapy; 2) maintain treatment outcomes by using a combined-modality approach with an abbreviated dose-intensive chemotherapy regimen with limited-volume, conformal radiotherapy for patients that are not in CR at the end of chemotherapy; and 3) reduce acute and long-term treatment sequelae by a) minimizing the cumulative doses of anthracyclines, bleomycin, and alkylating agents, b) increasing the number of complete responders, thus decreasing the number of patients requiring radiation, and c) tailoring the volume of radiation to initially involved nodal sites.

Condition	Intervention	Phase
Hodgkin Lymphoma	Drug: Stanford V Chemotherapy Radiation: Radiation Therapy	Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Reduced Duration Standford V Chemotherapy With Low-Dose Tailored-Field Radiation For Favorable Risk Pediatric Hodgkin Lymphoma

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

Primary Outcome Measures:

To increase the complete response rate after 8 weeks Stanford V by at least 20% compared to patients on HOD 99 after 8 weeks VAMP. [ Time Frame: 6.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	February 2009
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Stanford V Chemotherapy The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone Radiation: Radiation Therapy Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.

Arms

Assigned Interventions

1: Experimental

Drug: Stanford V Chemotherapy

The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone

Radiation: Radiation Therapy

Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.

Detailed Description:

Patients will be treated with 8 weeks of Stanford V chemotherapy. Radiation therapy will be omitted for patients achieving a complete response after 8 weeks of chemotherapy. Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed, previously untreated Hodgkin lymphoma.
Age: Participants must be 21 years of age or younger
Stage must be classified as one of the following:

Ann Arbor stage IA or IIA with:

Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR)
< 3 nodal regions involved on the same side of the diaphragm
No "E" lesion
Female patients who are post-menarchal must have a negative pregnancy test. Patients of reproductive potential must agree to use an effective contraceptive method.
Signed informed consent

Exclusion Criteria:

Intermediate or High risk disease, defined as Stage IB, IIIA, any IV or IA/IIA with "E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846742

Contacts

Contact: Monika Metzger, MD, MSc

1-866-278-5833

info@stjude.org

Locations

United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Monika Metzger, MD, MSc 866-278-5833 info@stjude.org
Principal Investigator: Monika Metzger, MD, MSc

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Monika Metzger, MD, MSc

St. Jude Children's Research Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	St. Jude Children's Research Hospital ( Monika Metzger, MD, MSc )
Study ID Numbers:	HOD08
Study First Received:	February 17, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00846742 History of Changes
Health Authority:	United States: Institutional Review Board

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

Hodgkin Lymphoma

Study placed in the following topic categories:

Prednisone
Immunoproliferative Disorders
Hodgkin Lymphoma, Childhood
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Vincristine
Vinblastine
Bleomycin

Etoposide phosphate
Doxorubicin
Lymphatic Diseases
Mechlorethamine
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Etoposide

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on May 07, 2009