Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:7/14/2016
Start Date:December 2009

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A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma

This phase III trial is studying how well giving combination chemotherapy together with
radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma.
Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either
by killing the cells or by stopping them from dividing. Radiation therapy uses high energy
x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy
may kill more cancer cells.

PRIMARY OBJECTIVES:

I. To maintain the overall survival (as defined by 4-year "second-event" free survival) for
subjects with high risk Hodgkin lymphoma at or above 95%.

SECONDARY OBJECTIVES:

I. To maintain 3-year event-free survival for subjects with high risk Hodgkin lymphoma at or
above 93%.

II. To maintain comparable overall survival (as defined by 4-year "second-event" free
survival) between subjects with high risk Hodgkin lymphoma who have a rapid or slow response
to the initial 2 cycles of ABVE-PC* by intensifying therapy through the addition of 2 cycles
of ifosfamide/vinorelbine in those with a slow early response.

III. To investigate whether very early response assessment measured by FDG-PET after 1 cycle
of chemotherapy identifies a subject cohort that can be studied in future trials and that is
distinguishable from currently defined RER after 2 cycles.

IV. To describe the patterns of relapse after ABVE-PC* and risk-adapted radiotherapy.

OUTLINE: This is a multicenter study.

INDUCTION THERAPY (ABVE-PC): Patients receive doxorubicin hydrochloride IV over 1-120
minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2, bleomycin sulfate IV
over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8,
etoposide phosphate IV over 1-2 hours on days 1-3, oral prednisone twice daily on days 1-7,
and filgrastim* SC or IV daily beginning on day 4 and continuing until blood counts recover.
Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or
disease progression.

NOTE: *Patients do not receive filgrastim on day 8.

Patients undergo clinical restaging and response assessment after 2 courses of induction
therapy. Patients with rapid early response (RER) or slow early response (SER) proceed to
consolidation therapy. Patients with progressive disease go off study.

CONSOLIDATION THERAPY: Patients are assigned to 1 of 2 consolidation therapy regimens based
on response to induction therapy.

REGIMEN I (RER): Patients receive 2 more courses of ABVE-PC in the absence of unacceptable
toxicity or disease progression.

REGIMEN II (SER): Patients receive ifosfamide IV continuously on days 1-4, vinorelbine
ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on
day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2
courses in the absence of unacceptable toxicity or disease progression. Patients then
receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease
progression.

Patients with a continued response after completion of consolidation therapy proceed to
risk-adapted radiotherapy.

RISK-ADAPTED RADIOTHERAPY: Beginning at 3 weeks after completion of consolidation
chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 3 weeks (14
fractions) in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed up periodically for 10 years.

Inclusion Criteria:

- Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the
following criteria:

- Classical disease

- Nodular lymphocyte-predominant disease

- Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:

- Unexplained weight loss > 10% within the past 6 months

- Unexplained recurrent fever > 38°C within the past month

- Recurrent drenching night sweats within the past month

- Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine
based on age/gender as follows:

- 0.4 mg/dL (1 to 5 months)

- 0.5 mg/dL (6 to 11 months)

- 0.6 mg/dL (12 to 23 months)

- 0.8 mg/dL (2 to 5 years)

- 1 mg/dL (6 to 9 years)

- 1.2 mg/dL (10 to 12 years)

- 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)

- 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

- AST or ALT < 2.5 times ULN for age

- Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to
large mediastinal mass from HL)

- FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal
mass fromHL)

- For children who are unable to cooperate for PFTs, the criteria are:

- No evidence of dyspnea at rest

- No exercise intolerance

- Pulse oximetry > 92% on room air

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No pathologic prolongation of QTc interval (> 450 milliseconds) on 12-lead ECG

- No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody
therapy), or radiotherapy

- At least 28 days since prior corticosteroids except for emergent treatment for
respiratory distress or spinal cord compression, or for treatment of allergy to
contrast agent required for CT scan

- No other concurrent cancer chemotherapy or immunomodulating agents (including
steroids)

- Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic
reactions allowed

- No concurrent pegfilgrastim
We found this trial at
157
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
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1201 Camino de Salud Northeast
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4900 Mueller Boulevard
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1600 7th Avenue
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1720 2nd Ave S
Birmingham, Alabama 35233
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666 Elm Street
Buffalo, New York 14263
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85 S Prospect St
Burlington, Vermont 5405
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1000 Blythe Blvd
Charlotte, North Carolina 28203
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5801 South Ellis Avenue
Chicago, Illinois 60637
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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700 Childrens Drive
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7777 Forest Ln # C840
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Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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