Hodgkin Lymphoma Clinical Trial
Official title:
Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma
Verified date | October 2023 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 88 |
Est. completion date | October 2028 |
Est. primary completion date | January 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Harvard Cancer Center | Boston | Massachusetts |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Packard Children's Hospital, Stanford University | Palo Alto | California |
United States | Children's Hospital of Illinois at OSF St. Francis Medical Center | Peoria | Illinois |
United States | Rady Children's Hospital- San Diego | San Diego | California |
United States | Maine Children's Cancer Program (MCCP) | Scarborough | Maine |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response Rate Estimate | 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 VAMP (NCT number: NCT00145600) .Complete response definition: Disappearance of all measurable or evaluable disease, signs, symptoms and biochemical changes related to the tumor. Biopsy confirmation is not mandatory. Residual PET-negative CT scan abnormalities representing > 75% reduction (as measured by the product of 2 perpendicular diameters of lesions by CT or MR imaging) in the original tumor volume will be considered scar tissue without active tumor. | 8 weeks | |
Secondary | Disease Failure Rate Within Radiation Fields | Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). | median 2 year post therapy | |
Secondary | Treatment Failure Patterns for Children Treated With Tailored-field Radiation | Descriptive statistics related to local/distant failure will be produced. The cumulative incidence of local failure will be estimated and effects of prognostic factors will be examined. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Relapse rate within the radiation fields will be estimated and confidence interval will also be calculated. | median 2 years post therapy | |
Secondary | Acute Hematologic Toxicities | Description of acute hematologic toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute hematologic toxicities were summarized descriptively. | 6 months | |
Secondary | Acute Infectious Toxicities | Description of acute infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute infectious toxicities were summarized descriptively. | 6 months | |
Secondary | 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 | Log-rank tests used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens. | median 2 years post therapy | |
Secondary | 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 | Log-rank tests used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens. | median 2 years post therapy | |
Secondary | 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 | 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 will be estimated by the Kaplan-Meier method. | median 2 years post therapy |
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