Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

NCT00352027 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HOD05NCI-2011-01253
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 6

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.

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's Disease

Outcome Measures

Primary Outcomes (1)

• 3-year Event-Free Survival Probability

  The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.

  3 years

Secondary Outcomes (75)

• Disease Failure Rate Within Radiation Fields

  3 years

• Local and Distant Failure for Children Treated With Tailored-field Radiation

  from first enrollment date up to 3 years follow-up

• Prognostic Factors for Treatment Failure: Age

  5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

• Patient Quality of Life (QoL), PedsQL v.4.0: Total Score

  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

• Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning

  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

Study Arms (1)

All Participants

EXPERIMENTAL

Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Drug: Adriamycin®; Drug: Vinblastine; Drug: Nitrogen Mustard; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Bleomycin; Drug: Etoposide; Drug: Prednisone; Biological: G-CSF; Procedure: Radiotherapy

Interventions

Adriamycin® DRUG

Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.

Also known as: Doxorubicin

All Participants

Vinblastine DRUG

Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.

Also known as: Velban®

All Participants

Nitrogen Mustard DRUG

Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.

Also known as: Mustargen®, Mechlorethamine Hydrochloride

All Participants

Cyclophosphamide DRUG

May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.

Also known as: Nitrogen Mustard Derivative

All Participants

Vincristine DRUG

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

Also known as: Velban®

All Participants

Bleomycin DRUG

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

Also known as: Blenoxane®

All Participants

Etoposide DRUG

Given IV on Days 1 and 2 of weeks 1-10.

Also known as: VP-16, Vepesid®

All Participants

Prednisone DRUG

Given PO every other day of weeks 1-12.

Also known as: Synthetic congener of hydrocortisone

All Participants

G-CSF BIOLOGICAL

Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).

Also known as: Filgrastim, Neupogen®

All Participants

Radiotherapy PROCEDURE

Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.

Also known as: Radiation therapy

All Participants

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (6)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Maine Children's Medical Center

Portland, Maine, 04102-3175, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Doxorubicin; Vinblastine; Mechlorethamine; Cyclophosphamide; Nitrogen Mustard Compounds; Vincristine; Bleomycin; Etoposide; Prednisone; Granulocyte Colony-Stimulating Factor; Filgrastim; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Therapeutics

Results Point of Contact

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

jamie.flerlage@stjude.org

901-595-0392

Study Officials

• Jamie Flerlage, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: July 20, 2006
• Primary Completion: May 1, 2015
• Study Completion: November 15, 2022
• Last Updated: September 22, 2023
• Results First Posted: October 7, 2016

Record last verified: 2023-09

Locations

US (6)