Therapy for Pediatric Hodgkin Lymphoma

NCT00145600 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HOD99NCI-2011-03721
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 5

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.

Conditions

Hodgkin Lymphoma

Keywords

Lymphoma; Hodgkin Disease

Outcome Measures

Primary Outcomes (1)

• Event-free Survival Probability by Risk Group

  Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula.

  Median 6.4 year follow-up

Secondary Outcomes (15)

• Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.

  At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

• Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.

  At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

• Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.

  At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

• Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.

  At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

• Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.

  At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Other Outcomes (1)

• Event-free Survival Probability by Risk Group at 10-year Follow-Up

  10-year follow-up after protocol enrollment

Study Arms (4)

Unfavorable Risk, Group 2

EXPERIMENTAL

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

Drug: 12 Week Stanford V Chemotherapy

Favorable Risk

EXPERIMENTAL

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

Drug: 4 cycles of VAMP chemotherapy

Intermediate Risk

EXPERIMENTAL

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

Drug: 2 alternating cycles of VAMP/COP chemotherapy

Unfavorable Risk, Group 1

EXPERIMENTAL

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

Drug: 3 alternating cycles of VAMP/COP chemotherapy

Interventions

12 Week Stanford V Chemotherapy DRUG

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

Unfavorable Risk, Group 2

4 cycles of VAMP chemotherapy 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.

Favorable Risk

2 alternating cycles of VAMP/COP chemotherapy DRUG

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

Intermediate Risk

3 alternating cycles of VAMP/COP chemotherapy DRUG

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

Unfavorable Risk, Group 1

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Ann Arbor IA or IIA with:
• Non-bulky mediastinal disease (\<33% mediastinal to thoracic ratio on chest x ray)
• 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)
• Stage must be classified as one of the following:
• Ann Arbor stage IIB, IIIB, or any IV

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (5)

Stanford University

Palo Alto, California, 94304, United States

Location

Maine Children's Cancer Program

Portland, Maine, 04102-3175, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• 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.

  PMID: 22735430 DERIVED

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Jamie Flerlage, MD
• Organization: St. Jude Children's Research Hospital

info@stjude.org

1-866-278-5833

Study Officials

• Jamie Flerlage, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: March 2, 2000
• Primary Completion: May 31, 2012
• Study Completion: November 5, 2021
• Last Updated: October 20, 2022
• Results First Posted: May 7, 2013

Record last verified: 2022-09

Locations

US (5)