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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01026220
First received: December 3, 2009
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Biological: bleomycin sulfate
Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: vinorelbine tartrate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Biological: filgrastim
Drug: ifosfamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Second-event-free survival at or above 95% [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Safety analysis and monitoring of toxic death [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • EFS of 93% [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Achieve a similar outcome for patients with RER and SER through intensification of therapy for SER patients [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Prognostic significance of "very early response" as assessed by PET scan [ Time Frame: After 1 course of therapy ] [ Designated as safety issue: No ]
  • Patterns of relapse after ABVE-PC and risk-adapted RT [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Grade 3 and 4 non-hematologic toxicities [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    These toxicities include specifically: GI toxicity and infections.

  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: December 2009
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen I (consolidation therapy)
Patients receive 2 more courses of ABVE-PC comprising 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 liposomal 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.
Biological: bleomycin sulfate
Given IV or SC
Other Names:
  • Blenoxane
  • BLEO
  • BLM
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: liposomal vincristine sulfate
Given IV
Other Names:
  • liposomal vincristine
  • Marqibo
  • vincristine liposomal
  • vincristine sulfate liposome injection
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: prednisone
Given IV
Other Names:
  • DeCortin
  • Deltra
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Experimental: Regimen II (consolidation therapy)
Patients receive ifosfamide IV continuously on days 1-4, vinorelbine tartrate IV over 6-10 minutes on days 1 and 5, and filgrastim SC or IV 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.
Biological: bleomycin sulfate
Given IV or SC
Other Names:
  • Blenoxane
  • BLEO
  • BLM
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: liposomal vincristine sulfate
Given IV
Other Names:
  • liposomal vincristine
  • Marqibo
  • vincristine liposomal
  • vincristine sulfate liposome injection
Drug: vinorelbine tartrate
Given IV
Other Names:
  • Eunades
  • navelbine ditartrate
  • NVB
  • VNB
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: prednisone
Given IV
Other Names:
  • DeCortin
  • Deltra
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: ifosfamide
Given IV
Other Names:
  • Cyfos
  • Holoxan
  • IFF
  • IFX
  • IPP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 from HL)

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026220

  Show 168 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Kara Kelly, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01026220     History of Changes
Other Study ID Numbers: AHOD0831, NCI-2011-01994, CDR0000660550, U10CA098543, COG-AHOD0831
Study First Received: December 3, 2009
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Ifosfamide
Etoposide phosphate
Liposomal doxorubicin
Vinorelbine
Etoposide
Doxorubicin
Prednisone
Vincristine
Bleomycin
Vinblastine
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014