Michael Link
Reduced Duration Standford V Chemotherapy With Low-Dose Tailored-Field Radiation For Favorable Risk Pediatric Hodgkin Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
Not yet recruitingCondition(s):
Intervention(s):
- Drug: Stanford V Chemotherapy
- Procedure: Radiation Therapy
Phase:
Phase 2Eligibility
Ages Eligible for Study:
Any Age to 21 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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
Additional Study Details
Official Title:
Reduced Duration Standford V Chemotherapy With Low-Dose Tailored-Field Radiation For Favorable Risk Pediatric Hodgkin LymphomaAnticipated start date:
2/1/2009Lead Sponsor:
St. Jude ChildrenInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
FactorialEndpoints:
Safety/EfficacyPrimary Outcomes:
- 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 ]
Total Number to be Enrolled:
64Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- HOD08
- NCT00846742
- PEDSHOD08
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
8/18/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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