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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: May 27, 2010
Last updated: July 23, 2015
Last verified: July 2015
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 Intervention Phase
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Progression-free survival (PFS) at 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complete response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 149
Study Start Date: May 2010
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
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 identifier: NCT01132807

  Show 95 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Principal Investigator: David J. Straus, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT01132807     History of Changes
Other Study ID Numbers: CALGB-50604, CALGB-50604, NCI-2011-02042, U10CA180821, CDR0000672913
Study First Received: May 27, 2010
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Etoposide phosphate
Fluorodeoxyglucose F18
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on November 27, 2015