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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk 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 Lymphoma

Intervention: Stanford V Chemotherapy (Drug); Radiation Therapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: St. Jude Children's Research Hospital

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

Overall contact:
Monika Metzger, MD, MSc, Phone: 1-866-278-5833, Email: referralinfo@stjude.org

Summary

This phase II trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride, vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells for those patients that still had residual cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started.

Clinical Details

Official title: Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma

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

Primary outcome: Proportion of patients that will not require any radiotherapy by at least 20% more compared to the favorable risk arm in HOD99

Secondary outcome:

Disease failure rate within radiation fields

Treatment failure patterns for children treated with tailored-field radiation

Acute hematologic and infectious toxicity incidents as assessed by CTCAE version 3.0

Comparison of event-free and overall survival distributions, cumulative incidence of local failure, and toxicities of patients treated on this study to outcome and toxicities in the favorable risk group of HOD99

Comparison of event-free survival distributions between patients that will not be prescribed radiotherapy after 8 weeks Stanford V and those patients on HOD99 that received VAMP without radiotherapy

Event-free survival distributions of favorable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored-field radiation

Detailed description: Patients receive doxorubicin hydrochloride intravenously (IV) and vinblastine IV on day 1 of weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks 3 and 7; and prednisone orally (PO) three times daily every other day for 8 weeks. Two to 3 weeks after all chemotherapy is given, patients not achieving a complete response undergo radiation therapy to individual nodal sites (tailored fields). PRIMARY OBJECTIVES: 1. To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks vincristine, doxorubicin hydrochloride, methotrexate and prednisone (VAMP). SECONDARY OBJECTIVES: 1. To estimate the disease failure rate within the radiation fields. 2. To examine patterns of treatment failure for children treated with low dose tailored field radiation therapy. 3. To describe acute hematologic and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia, and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3. 0. 4. To compare the survival distributions (event-free and overall) and cumulative incidence of local failure and toxicities of favorable risk patients treated with 8 weeks of Stanford V chemotherapy and low-dose tailored-field radiation to those on the favorable risk group of the HOD 99 study that received VAMP and low-dose involved-field radiation. 5. To compare the survival distributions between patients that will not be prescribed radiotherapy after 8 weeks Stanford V and those patients on HOD 99 that did not receive radiotherapy after VAMP. 6. To estimate the event-free survival distributions of favorable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored field radiation.

Eligibility

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

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

- If re-evaluation of a patient's disease shows intermediate risk features, the patient

will be removed from the HOD08. Exclusion Criteria:

- Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with

"E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy

Locations and Contacts

Monika Metzger, MD, MSc, Phone: 1-866-278-5833, Email: referralinfo@stjude.org

Packard Children's Hospital, Stanford University, Palo Alto, California 94304, United States; Recruiting
Michael Link, MD, Phone: 650-495-8815, Email: mlink@stanford.edu
Michael Link, MD, Principal Investigator

Rady Children's Hospital- San Diego, San Diego, California 92123, United States; Recruiting
Amy E Geddis, MD, PhD, Phone: 858-966-5811, Email: cmadigan@rchsd.org
Amy E Geddis, MD, Ph.D, Principal Investigator

Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine 04074, United States; Recruiting
Anne Rossi, MD, Phone: 207-885-7565, Email: rossia@mmc.org
Anne Rossi, MD, Principal Investigator

Dana-Farber Harvard Cancer Center, Boston, Massachusetts 02115, United States; Recruiting
Amy Billett, MD, Phone: 617-632-5640, Email: amy_billett@dfci.harvard.edu
Amy Billett, MD, Principal Investigator

Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States; Recruiting
Alison Friedmann, MD, Phone: 617-726-2737, Email: afriedmann@partners.org
Alison Friedmann, MD, Principal Investigator

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

Additional Information

St. Jude Children's Research Hospital

Clinical Trials Open at St. Jude

Starting date: February 2009
Last updated: June 11, 2015

Page last updated: August 23, 2015

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