HOD08: Combination Chemotherapy with or without Radiation Therapy in Treating Young Patients with Favorable-Risk Hodgkin Lymphoma

Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy for Favorable Risk Pediatric Hodgkin Lymphoma

Categories:

Leukemia / Lymphoma

Phase I/II

Diseases Treated:

Hodgkin lymphoma

Eligibility Overview:

  • Diagnosis of early-stage Hodgkin lymphoma 
  • Hodgkin lymphoma that has not been previously treated
  • 21 years of age or younger
  1. Brief Summary

    This phase 2 trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with favorable-risk Hodgkin lymphoma.

    Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride, vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

    Radiation therapy uses high-energy X-rays to kill cancer cells for those patients that still had residual cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started.

    Primary Objective

    To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks vincristine, doxorubicin hydrochloride, methotrexate and prednisone (VAMP).

    Trial Outline

    Drug: Stanford V Chemotherapy

    The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone

    Radiation: Radiation Therapy

    Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.

    Study Arm

    Experimental: Treatment

    Participants receive Stanford V Chemotherapy with or without radiation therapy. Patients receive doxorubicin hydrochloride IV and vinblastine IV on day 1 of weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks 3 and 7; and prednisone PO three times 2-3 weeks after completion of chemotherapy, patients not achieving complete response undergo radiation therapy to individual nodal sites (tailored fields)

    Interventions

    Drug: Stanford V Chemotherapy
    Radiation: Radiation Therapy

    Eligibility Criteria

    Inclusion Criteria:

    • Histologically confirmed, previously untreated Hodgkin lymphoma.
    • Age: Participants must be 21 years of age or younger
    • Stage must be classified as one of the following:
    • Ann Arbor stage IA or IIA with:
      • Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR)
      • < 3 nodal regions involved on the same side of the diaphragm
      • No "E" lesion
    • Female patients who are post-menarchal must have a negative pregnancy test. Patients of reproductive potential must agree to use an effective contraceptive method.
    • Signed informed consent
    • If re-evaluation of a patient's disease shows intermediate risk features, the patient will be removed from the HOD08.

    Exclusion Criteria:

    • Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with "E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy

    Study Design

    • Endpoint Classification: Safety/Efficacy Study
    • Intervention Model: Single Group Assignment
    • Masking: Open Label
    • Primary Purpose: Treatment
  2. About this clinical trial

    Hodgkin lymphoma, especially in its early stages, is one of the most treatable and curable childhood cancers. The standard treatment for early-stage Hodgkin lymphoma involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to kill cancer cells).

    Most patients can be cured from Hodgkin lymphoma. Some may experience serious side effects from treatment later in life. This can include problems with:

    • Growth
    • Fertility
    • Some organ functions
    • Development of another kind of cancer (called secondary cancer)

    It is thought that if patients with early-stage Hodgkin lymphoma can be successfully treated with less intense therapy, they may have fewer serious effects later in life.

    Purpose of this clinical trial

    The main goal of this clinical trial is to find out if lowering the amount of chemotherapy and radiation therapy will reduce side effects during treatment and later in life while keeping the same high cure rate of Hodgkin lymphoma.

    Treatment

    In this Phase II clinical trial, all participants will receive eight weeks of chemotherapy. This is a shorter amount of time, with fewer total doses of chemotherapy drugs, than the standard chemotherapy used in other patients with early stage Hodgkin lymphoma. If your child’s lymphoma goes away after the eight weeks of chemotherapy, then treatment will be finished. Your child will not have radiation therapy.

    Treatment with fewer doses of chemotherapy (over a shorter period of time) and without radiation therapy is considered the experimental treatment in this clinical trial.

    If your child’s lymphoma does not go away after eight weeks of chemotherapy, your child will be given radiation therapy. The radiation dose will be lower than the one most commonly used, and it will be directed only to the tumor site so that less normal tissue will be exposed to radiation.

    Eligibility overview

    • Diagnosis of early-stage Hodgkin lymphoma
    • Hodgkin lymphoma that has not been previously treated
    • 21 years of age or younger
  3. HOD08  Quick View

    Sponsor

    St. Jude Children’s Research Hospital

    ClinicalTrials.gov identifier

    NCT00846742

    Trial start date

    February 2009

    Estimated enrollment

    80

    Study type

    Interventional

    Study phase

    Phase 2

    Condition

    Hodgkin Lymphoma

    Ages

    Up to 21 years

    Principal investigator

    Monika Metzger, MD, MSc

    Study sites

    St. Jude Children’s Research Hospital and collaborating sites in the U.S.

    For a consultation or to discuss HOD08

    St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Monika Metzger, MD, MSc

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.