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Clinical Trials (PDQ®)

Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, Diagnostic, TreatmentActive18 to 60NCI, OtherCALGB-50801
CDR0000669076, NCI-2011-02034, NCT01118026

Trial Description

Summary

RATIONALE: 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 chemotherapy together with radiation therapy may kill more cancer cells. Diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors plan the best treatment.

PURPOSE: This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma.

Further Study Information

OBJECTIVES:

Primary

  • To determine the progression-free survival (PFS) at 36 months from enrollment of patients with bulky stage I or II Hodgkin lymphoma treated with ABVD alone or followed by escalated BEACOPP and involved-field radiation therapy.

Secondary

  • To evaluate the complete response rate in patients diagnosed with bulky stage I and II Hodgkin lymphoma following PET-response-adapted chemotherapy with or without radiotherapy.
  • To determine the predictive value of semiquantitative evaluation of fludeoxyglucose (FDG) uptake using various semiquantitative approaches at baseline, after 2 courses of ABVD, and after completion of therapy.
  • To determine the predictive value of volumetric vs 2-dimensional (2-D) measurement changes on CT scan between baseline and after 2 courses, at the end of chemotherapy (PET negative patients only), and after radiotherapy (PET positive patients only), and compare with PET parameters.
  • To determine if changes in both qualitative and semiquantitative FDG-PET findings/changes between baseline and after course 2, at the end of chemotherapy (PET negative patients only), and after radiotherapy (PET positive patients only) with combination analyses incorporating changes obtained from dedicated CT scans, correlates with response and PFS.
  • To compare the predictive value of both qualitative and semiquantitative FDG-PET changes, 2-D and volumetric CT changes, and combinatorial analyses (PET + dedicated CT data) with molecular parameters and conventional parameters, including International Prognostic Score.
  • To assess whether elevated baseline serum soluble CD30 (sCD30), IL10, CCL17, and CCL22 correlate with clinical response and PFS.
  • To assess whether persistent or recurrent elevation of serial serum sCD30, IL10, CCL17, or CCL22 correlate with relapse/progression or PET scan results.
  • To confirm independently useful tissue biomarkers (bcl-2, MAL, FOXP3, GzB) for risk stratification in patients with bulky stage I or II Hodgkin lymphoma treated with this regimen.

OUTLINE: This is a multicenter study.

  • ABVD chemotherapy: All patients receive doxorubicin hydrochloride IV over 3-5 minutes, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo a PET/CT scan and CT scan of the neck (if it was positive at baseline), chest, abdomen, and pelvis. Patients who are PET-positive proceed to escalated BEACOPP chemotherapy. Patients who are PET-negative receive 4 additional courses of ABVD chemotherapy in the absence of disease progression or unacceptable toxicity.
  • Escalated BEACOPP chemotherapy: Patients receive doxorubicin hydrochloride IV over 3-5 minutes and cyclophosphamide IV over 60 minutes on day 1; etoposide IV over 60 minutes on days 1, 2, and 3; oral procarbazine hydrochloride once daily on days 1-7; oral prednisone on days 1-14; and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo another PET/CT scan and CT scan of the neck (if it was positive at baseline), chest, abdomen, and pelvis. Patients then undergo involved-field radiation therapy 5 days per week for 3½ weeks (for a total of 30.6 Gy).

Within 3-8 weeks after completion of chemotherapy, patients undergo an additional PET/CT scan (utilizing fludeoxyglucose F 18) and CT scan of the neck (if it was positive at baseline), chest, abdomen, and pelvis. Patients who are PET-negative proceed to follow up. Patients who are PET-positive undergo a biopsy*, patients with a negative biopsy proceed to follow up, and patients with a positive biopsy are treated at the discretion of the investigator.

NOTE: *Patients for whom a biopsy is neither clinically appropriate nor medically feasible proceed to follow up. Patients who defer the biopsy undergo scanning 3 months later and then undergo biopsy as above.

Blood and serum samples may be collected periodically for biomarker and IHC analysis.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for 7 years.

Eligibility 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
  • Patients with "E" extensions are eligible provided all other criteria have been met NOTE: *Patients must submit pathology materials within 60 days of study registration. Core-needle biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping. Fine-needle aspirates are not acceptable. If multiple specimens are available, submit the most recent.
  • No nodular lymphocyte-predominant Hodgkin lymphoma
  • Has a mediastinal mass > 0.33 maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter

PATIENT CHARACTERISTICS:

  • Performance status 0-2
  • ANC ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 2 mg/dL
  • Bilirubin ≤ 2 times upper limit of normal (ULN) (in the absence of Gilbert disease)
  • AST ≤ 2 times ULN
  • 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)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No "currently active" second malignancy other than nonmelanoma 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 < 30% risk of relapse
  • Patients with known HIV are eligible provided their CD4 count is > 350, and they are on concurrent antiretrovirals
  • An HIV test is required for patients with a history of IV drug abuse or any behavior associated with an increased risk of HIV

PRIOR CONCURRENT THERAPY:

  • No prior treatment (chemotherapy or radiotherapy) for Hodgkin lymphoma
  • No concurrent zidovudine or stavudine as part of the antiretroviral therapy for HIV-positive patients
  • No concurrent hormones or other chemotherapeutic agents, except for the following:
  • Steroids for adrenal failure
  • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • Dexamethasone on the day of chemotherapy for (acute) chemotherapy-induced nausea or vomiting
  • No concurrent intensity-modulated radiation therapy or cobalt-60

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Ann S. LaCascePrincipal Investigator

Trial Sites

U.S.A.
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
Illinois
  Chicago
 University of Chicago Cancer Research Center
 Chadi Nabhan Ph: 773-834-7424
  Evanston
 CCOP - Evanston
 David L. Grinblatt Ph: 847-570-2109
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Ann S. LaCasce Ph: 866-790-4500
 Massachusetts General Hospital
 Ann S. LaCasce Ph: 866-790-4500
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Nancy L. Bartlett Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 St. John's Regional Health Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
Nebraska
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Philip J. Bierman Ph: 800-999-5465
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Elizabeth M Bengtson Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New York
  Syracuse
 SUNY Upstate Medical University Hospital
 Teresa C. Gentile Ph: 315-464-5476
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 David Weldon Miller Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Concord
 Batte Cancer Center at Northeast Medical Center
 David Weldon Miller Ph: 704-355-2884
  Durham
 Duke Cancer Institute
 Jeffrey Crawford Ph: 888-275-3853
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 David Duane Hurd Ph: 336-713-6771
Ohio
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Kristie A. Blum Ph: 866-627-7616
  Email: osu@emergingmed.com
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Toledo
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
South Carolina
  Greenville
 Bon Secours St. Francis Health System
 Charles E Bowers Ph: 800-486-5941
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Charles E Bowers Ph: 800-486-5941
Vermont
  Berlin
 Mountainview Medical
 Gurpreet Lamba Ph: 718-818-2952
  Burlington
 Vermont Cancer Center at University of Vermont
 Gurpreet Lamba Ph: 718-818-2952
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Beata Holkova Ph: 804-628-1939
Wisconsin
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01118026
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.