Chemotherapy + Radiation for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Matt Ehrhardt, MD, MS

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II 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.

Research Team

Matt Ehrhardt, MD, MS

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for young patients, 21 years or younger, with a type of cancer called favorable-risk Hodgkin lymphoma. They should not have been treated before and must have specific early stages of the disease without extensive spread. Girls after puberty need a negative pregnancy test and all participants able to have children must use birth control.

Inclusion Criteria

My cancer is early stage with limited spread and no extranodal involvement.

Female patients who are post-menarchal must have a negative pregnancy test. Patients of reproductive potential must agree to use an effective contraceptive method

If my disease is reassessed as intermediate risk, I will be taken off the HOD08 trial.

Exclusion Criteria

My cancer is at an advanced stage or has specific high-risk features.

Treatment Details

Interventions

• Bleomycin (Anti-tumor antibiotic)
• Doxorubicin Hydrochloride (Alkylating agents)
• Etoposide (Topoisomerase II inhibitors)
• Mechlorethamine Hydrochloride (Alkylating agents)
• Prednisone (Corticosteroid)
• Radiation Therapy (Radiation)
• Vinblastine (Vinca alkaloids)
• Vincristine Sulfate (Vinca alkaloids)

Trial Overview The study is testing how well a mix of chemotherapy drugs works compared to the same chemo plus radiation therapy in these young patients. The goal is to see if adding radiation helps more when some cancer remains after chemo, while trying to preserve healthy body parts.

Participant Groups

Group I: Treatment Experimental Treatment 2 Interventions

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 orally (PO) three times daily every other day of weeks 1-8. Beginning 2-3 weeks after completion of chemotherapy, patients not achieving complete response undergo radiation therapy to individual nodal sites (tailored fields)

Bleomycin is already approved in Canada for the following indications:

Approved in Canada as Bleomycin for:

• Hodgkin's lymphoma
• Non-Hodgkin's lymphoma
• Testicular cancer
• Ovarian cancer
• Malignant pleural effusions

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Dr. James R. Downing

St. Jude Children's Research Hospital

Chief Executive Officer since 2014

MD from University of Michigan Medical School

Dr. Ellis J. Neufeld

St. Jude Children's Research Hospital

Chief Medical Officer since 2017

MD, PhD from Harvard Medical School