Clinical trial NCT00846742: Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma
Official title: Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 88
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Complete Response Rate Estimate
timeFrame: 8 weeks
Secondary outcomes:
measure: Acute Hematologic Toxicities
timeFrame: 6 months
measure: Acute Infectious Toxicities
timeFrame: 6 months
measure: Disease Failure Rate Within Radiation Fields
timeFrame: median 2 year post therapy
measure: Treatment Failure Patterns for Children Treated With Tailored-field Radiation
timeFrame: median 2 years post therapy
measure: Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Age
timeFrame: median 2 years post therapy
measure: Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Gender
timeFrame: median 2 years post therapy
measure: Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Stage
timeFrame: median 2 years post therapy
measure: Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Histology
timeFrame: median 2 years post therapy
measure: Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99
timeFrame: median 2 years post therapy
measure: Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99
timeFrame: median 2 years post therapy
measure: Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy
timeFrame: median 2 years post therapy
measure: 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
timeFrame: median 2 years post therapy
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Packard Children's Hospital, Stanford University
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital- San Diego
state: California
city: Peoria
country: United States
facility: Children's Hospital of Illinois at OSF St. Francis Medical Center
state: Illinois
city: Scarborough
country: United States
facility: Maine Children's Cancer Program (MCCP)
state: Maine
city: Boston
country: United States
facility: Dana-Farber Harvard Cancer Center
state: Massachusetts
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Matt Ehrhardt, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: