Therapy for Pediatric Hodgkin Lymphoma

St. Jude Children's Research Hospital

Status and phase: Completed; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: 3 alternating cycles of VAMP/COP chemotherapy; Drug: 12 Week Stanford V Chemotherapy; Drug: 2 alternating cycles of VAMP/COP chemotherapy; Drug: 4 cycles of VAMP chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00145600

HOD99

NCI-2011-03721 (Registry Identifier)

Details and patient eligibility

About

With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.

Full description

This study will evaluate the following objectives:

Primary Objectives:

1. To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with favorable risk Hodgkin's disease who achieve a complete response after 2 cycles of VAMP chemotherapy.
2. To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients with favorable risk Hodgkin's disease who achieve a partial response after 2 cycles of VAMP chemotherapy.
3. To evaluate the efficacy of 2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT in children with intermediate risk Hodgkin's disease.
4. To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children with unfavorable risk Hodgkin's disease.

Secondary Objectives:

1. To evaluate patient quality of life during and after treatment from the patient and parent perspective.
2. To compare patient and parental ratings of treatment-related symptoms and patient physical, psychological, social and cognitive functioning before the first treatment (T1 - baseline); after Cycle 2 or after 8 weeks of Stanford V (T2 - Evaluate Response); after cycle 4 or after 12 weeks of Stanford V and before or on the first day of radiation (as applicable) (T3); at the conclusion of radiation or within a few days following the end of radiation (as applicable) (T4); and at 3 to 6 months after completion of therapy follow-up evaluation (T5).

Enrollment: 296 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Eligible patients must have histologically confirmed previously untreated Hodgkin's disease (Patients receiving limited emergent RT or steroid therapy because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
• Patients must be 21 years of age or younger
• Ann Arbor stages IIB-IV
• No prior treatment.
• No pregnant or lactating women.
• Signed informed consent
• If re-evaluation of a patient's disease shows favorable risk features or intermediate risk features, the patient will be removed from the HOD99 study and consented to the respective HOD08 or HOD05 study.

Inclusion: treatment of favorable risk features:

• Ann Arbor IA or IIA with:

  1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x ray)

  2. Ann Arbor stage IA or IIA with any of the following features: (1) "E" lesions (s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)

     Inclusion: unfavorable risk features:

• Stage must be classified as one of the following:

  1. Ann Arbor stage IIB, IIIB, or any IV

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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296 participants in 4 patient groups

Unfavorable Risk, Group 2

Experimental group

Description:

Unfavorable risk, group 2 arm in patients with Hodgkin's disease (n=146)

Treatment:

Drug: 12 Week Stanford V Chemotherapy

Favorable Risk

Experimental group

Description:

Favorable Risk arm in patients with Hodgkin's Disease (n=91).

Treatment:

Drug: 4 cycles of VAMP chemotherapy

Intermediate Risk

Experimental group

Description:

Intermediate Arm in patients with Hodgkins's disease (n=46).

Treatment:

Drug: 2 alternating cycles of VAMP/COP chemotherapy

Unfavorable Risk, Group 1

Experimental group

Description:

Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).

Treatment:

Drug: 3 alternating cycles of VAMP/COP chemotherapy