Clinical trial NCT00352027: Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Official title: Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Disease
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2006-07-14
Enrollment: 81
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: The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Detailed description: Treatment Plan Description:

Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9

Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)

Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11

Prednisone\* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12

G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

\* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

Eligibility criteria: Inclusion Criteria:

* Patient is less than or equal to 21 years of age
* Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
* Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion Criteria:

* Patients with favorable risk features
* Patients with unfavorable risk features
* Patients who have received prior therapy for Hodgkin lymphoma.

Primary outcomes:
measure: 3-year Event-Free Survival Probability
timeFrame: 3 years
Secondary outcomes:
measure: Disease Failure Rate Within Radiation Fields
timeFrame: 3 years
measure: Local and Distant Failure for Children Treated With Tailored-field Radiation
timeFrame: from first enrollment date up to 3 years follow-up
measure: Prognostic Factors for Treatment Failure: Age
timeFrame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
measure: Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Worry
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), PedsQL v.3.0: Communication
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Patient Quality of Life (QoL), Symptom Distress Scale
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
timeFrame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
timeFrame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance
timeFrame: 6 months after the completion of therapy
measure: Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication
timeFrame: 6 months after the completion of therapy
measure: 3-year Event-free Survival (EFS) Probability
timeFrame: 3 years
measure: 3-year Overall Survival (OS) Probability
timeFrame: 3-years
measure: 3-year Local Failure-free Survival Probability
timeFrame: 3 years
measure: Toxicities With Grade >1
timeFrame: 3 years
measure: Prognostic Factors for Treatment Failure: Gender
timeFrame: 3 years follow-up
measure: Prognostic Factors for Treatment Failure: Histology
timeFrame: 3 years follow-up
measure: Prognostic Factors for Treatment Failure: Stage
timeFrame: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up
measure: Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)
timeFrame: 1, 2, 5, and 10 years post therapy
measure: Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)
timeFrame: 1, 2, 5, and 10 years post therapy
measure: Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)
timeFrame: 1, 2, 5, and 10 years post therapy
measure: Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)
timeFrame: 1, 2, 5, and 10 years post therapy
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Portland
country: United States
facility: Maine Children's Medical Center
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
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: Jamie Flerlage, MD
role: PRINCIPAL_INVESTIGATOR
References: