Therapy for Pediatric Hodgkin Lymphoma

NCT ID: NCT00145600

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-02
• Study Completion Date: 2021-11-05

Brief Summary

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.

Detailed 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).

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unfavorable Risk, Group 2

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

Group Type: EXPERIMENTAL

12 Week Stanford V Chemotherapy

Intervention Type: DRUG

12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children

Favorable Risk

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

Group Type: EXPERIMENTAL

4 cycles of VAMP chemotherapy

Intervention Type: DRUG

4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.

Intermediate Risk

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

Group Type: EXPERIMENTAL

2 alternating cycles of VAMP/COP chemotherapy

Intervention Type: DRUG

2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.

Unfavorable Risk, Group 1

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

Group Type: EXPERIMENTAL

3 alternating cycles of VAMP/COP chemotherapy

Intervention Type: DRUG

3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT

Interventions

12 Week Stanford V Chemotherapy

12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children

Intervention Type: DRUG

4 cycles of VAMP chemotherapy

4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.

Intervention Type: DRUG

2 alternating cycles of VAMP/COP chemotherapy

2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.

Intervention Type: DRUG

3 alternating cycles of VAMP/COP chemotherapy

3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT

Intervention Type: DRUG

Eligibility 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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie Flerlage, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

Stanford University

Palo Alto, California, United States

Maine Children's Cancer Program

Portland, Maine, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

References

Metzger ML, Weinstein HJ, Hudson MM, Billett AL, Larsen EC, Friedmann A, Howard SC, Donaldson SS, Krasin MJ, Kun LE, Marcus KJ, Yock TI, Tarbell N, Billups CA, Wu J, Link MP. Association between radiotherapy vs no radiotherapy based on early response to VAMP chemotherapy and survival among children with favorable-risk Hodgkin lymphoma. JAMA. 2012 Jun 27;307(24):2609-16. doi: 10.1001/jama.2012.5847.

Reference Type: DERIVED

PMID: 22735430 (View on PubMed)

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

NCI-2011-03721

Identifier Type: REGISTRY

Identifier Source: secondary_id

HOD99

Identifier Type: -

Identifier Source: org_study_id