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Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma (ACRIN-6700)

This study has been terminated.
(slow accrual)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01390584
First received: July 7, 2011
Last updated: July 7, 2017
Last verified: July 2017
  Purpose

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, 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. Comparing results of imaging procedures, such as PET scans and CT scans, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan works in treating patients with stage I or stage II Hodgkin lymphoma.


Condition Intervention Phase
Lymphoma Drug: ABVD Induction Drug: Escalated BEACOPP Drug: Standard BEACOPP Diagnostic Test: PET Radiation: INRT Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
PEt
Masking: None (Open Label)
Masking Description:
In order to better define the optimal therapy for patients with Stage I/II HL with bulky mediastinal disease in our study, we propose incorporating interim functional imaging with PET scans after 2 cycles of ABVD to risk stratify patients. Extrapolating from data in advanced HL, patients who are PET+ will presumably have a worse outcome; therefore, in this select group therapy will be altered to a more aggressive regimen. An interim PET scan may prospectively identify patients unlikely to be cured with standard CMT and a therapeutic change to escalated BEACOPP may improve outcomes for this subgroup and spare the morbidity of a stem cell transplantation. In contrast, for PET- patients, who presumably will have a better outcome, standard CT will be continued and followed by INRT
Primary Purpose: Treatment
Official Title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 36-month ]
    36-month PFS


Secondary Outcome Measures:
  • PET-positive rate [ Time Frame: 36-month ]
    PET-positive rate

  • PET-negative rate [ Time Frame: 36-month ]
    PET-negative rate

  • Complete response [ Time Frame: 36-Month ]
    Complete response


Enrollment: 6
Actual Study Start Date: April 2, 2012
Study Completion Date: January 24, 2014
Primary Completion Date: January 24, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Centralized PET review
Centralized PET review of patients after 2 cycles of ABVD induction followed by 4 additional cycles of ABVD (escalated BEACOPP or standard BEACOPP) followed by involved nodal radiotherapy [INRT] of 30-30.6 Gy.
Drug: ABVD Induction
Step 1 Induction (Arm I) - ABVD Treatment : (Cycle Length: 28 days)
Other Names:
  • bleomycin sulfate
  • Doxorubicin
  • Dacarbazine
  • Vinblastine
Drug: Escalated BEACOPP
Escalated BEACOPP (Cycle Length: 21 days)
Other Name: BEACOPP
Drug: Standard BEACOPP
Standard BEACOPP (Cycle Length: 21 days)
Other Name: BEACOPP
Diagnostic Test: PET
fludeoxyglucose F 18 Imaging exam
Other Name: PET/CT
Radiation: INRT
selective external radiation therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008)

    • Nodular lymphocyte-predominant Hodgkin lymphoma is excluded
  • Patients must have clinical stage IA, IB, IIA, or IIB disease

    • Patients with "E" extensions will be eligible if all other criteria have been met
  • Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images
  • Bone marrow biopsy is required

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine ≤ 2 mg/dL
  • Direct bilirubin ≤ 2 mg/dL
  • AST/ALT ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
  • No "currently active" second malignancy other than non-melanoma skin cancers

    • Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
  • LVEF by ECHO or MUGA normal unless thought to be disease related
  • DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related
  • Patients with a history of intravenous drug abuse, or any behavior associated with an increased risk of HIV infection, should be tested for exposure to the HIV virus, and an HIV test is required for entry on this protocol
  • HIV-positive patients are eligible if they have CD4 counts ≥ 400/mm³ and are on concurrent antiretrovirals

    • Patient HIV status must be known prior to registration
    • HIV-positive patients must not have multi-drug resistant HIV infections; CD4 counts < 400/mm³; or other concurrent AIDS-defining conditions

PRIOR CONCURRENT THERAPY:

  • No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
  • Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³) allowed
  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: NCT01390584

Locations
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Pennsylvania
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Ranjana Advani, MD Stanford University
  More Information

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01390584     History of Changes
Other Study ID Numbers: CDR0000702859
ECOG-E2410, ACRIN 6700 ( Other Identifier: ACRIN Foundation )
U01CA079778 ( U.S. NIH Grant/Contract )
U01CA080098 ( U.S. NIH Grant/Contract )
Study First Received: July 7, 2011
Last Updated: July 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by American College of Radiology Imaging Network:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
adult favorable prognosis Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma
adult unfavorable prognosis Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Cyclophosphamide
Etoposide
Prednisone
Vincristine
Procarbazine
Antibiotics, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on August 23, 2017