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Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01132807
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:
This phase II trial studies how well chemotherapy based on positron emission tomography (PET) scan works in treating patients with stage I or stage II 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. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: Bleomycin Sulfate Drug: Doxorubicin Hydrochloride Drug: Procarbazine Hydrochloride Drug: Vinblastine Sulfate Drug: Dacarbazine Drug: Cyclophosphamide Drug: Etoposide phosphate Drug: prednisone Drug: Radiation Therapy Radiation: Fludeoxyglucose F-18 Procedure: computed tomography Procedure: Positron Emission Tomography Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma
Study Start Date : May 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
 Biological: Bleomycin Sulfate
Given IV

Drug: Doxorubicin Hydrochloride
Given IV

Drug: Procarbazine Hydrochloride
Given PO

Drug: Vinblastine Sulfate
Given IV

Drug: Dacarbazine
Given IV

Drug: Cyclophosphamide
Given IV

Drug: Etoposide phosphate
Given IV

Drug: prednisone
Given PO

Drug: Radiation Therapy
Undergo radiation therapy

Radiation: Fludeoxyglucose F-18
Undergo FDG PET/CT

Procedure: computed tomography
Undergo FDG PET/CT

Procedure: Positron Emission Tomography
Undergo FDG PET/CT


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD [ Time Frame: 36 Months ]
    The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included.

  2. 36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation. [ Time Frame: at 36 months ]
    All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT.


Secondary Outcome Measures :
  1. Complete Response Rate [ Time Frame: Up to 5 years ]
    A Complete Response (CR) was defined as having the following conditions: 1. A complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. In patients with a PET scan that was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET-negative. A Complete Response rate was defined as the number of patients who achieved a CR divided by the number of patients that were eligible for analysis in each group. The CR rate was calculated for patients that completed 4 cycles of ABVD and for patients that completed 2 cycles of ABVD and 2 cycles of BEACOPP and IFRT.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* Hodgkin lymphoma

    • Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor Staging Classification system
    • Subclassified according to the WHO modification of the Rye Classification
    • "E" extension allowed provided all other criteria have been met NOTE: *Pathology materials must be submitted within 60 days of study registration. Core-needle biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping. Fine-needle aspirates not allowed. If multiple specimens are available, submit the most recent.
  • No nodular lymphocyte-predominant Hodgkin lymphoma
  • No mediastinal mass > 0.33 maximum intrathoracic diameter by standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy > 10 cm in its largest diameter

  • Measurable disease by physical examination or imaging studies

    • Any tumor mass measurable in two dimensions and > 1 cm (or 1.5 cm if 0.5 cm slices are used, as in spiral CT scans) allowed

    • Lesions that are considered intrinsically non-measurable include:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Lesions that are situated in a previously irradiated area

PATIENT CHARACTERISTICS:

  • Performance status 0-2
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL
  • Serum creatinine ≤ 2 mg/dL
  • Bilirubin ≤ 2 mg/dL
  • AST ≤ 2 times upper limit of normal
  • LVEF normal by ECHO or MUGA
  • DLCO ≥ 60% with no symptomatic pulmonary disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

  • Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL

    • Patients must not have multi-drug resistant HIV infections (i.e., concurrent AIDS-defining conditions)
    • An HIV test is required for patients with a history of IV drug abuse or any behavior associated with an increased risk of HIVinfection

  • No "currently active" second malignancy other than nonmelanoma skin cancers

    • Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered by their physician to be at < 30% risk of relapse

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior chemotherapy or radiotherapy for Hodgkin lymphoma

    • 1 course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) allowed and will be considered the first course
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132807


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David J. Straus, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01132807    
Other Study ID Numbers: CALGB-50604
CALGB-50604
NCI-2011-02042 ( Registry Identifier: NCI Clinical Trial Reporting Program )
U10CA180821 ( U.S. NIH Grant/Contract )
CDR0000672913 ( Registry Identifier: NCI Physician Data Query )
First Posted: May 28, 2010    Key Record Dates
Results First Posted: June 14, 2021
Last Update Posted: June 14, 2021
Last Verified: June 2021
Keywords provided by Alliance for Clinical Trials in Oncology:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Dacarbazine
Doxorubicin
Liposomal doxorubicin
Etoposide
Bleomycin
 Vinblastine
Etoposide phosphate
Procarbazine
Fluorodeoxyglucose F18
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors