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Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma


OBJECTIVES:

Primary

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

- To compare the PFS of patients who are PET positive versus PET negative after 2 courses
of ABVD.

Secondary

- To evaluate the complete response rate in patients treated with these regimens.

- To determine the predictive value of semiquantitative evaluation of FDG/PET uptake
using various approaches at baseline, after 2 courses of AVBD, and at completion of
therapy.

- To determine the predictive value of volumetric changes on CT scan after courses 2 and
4 of ABVD and compare with PET parameters with and without combination analyses
(PET+dedicated CT data).

- To compare the predictive value of metabolic parameters/changes both visual and
quantitative, IHP criteria, volumetric CT changes, molecular parameters, and
conventional parameters, including initial 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 elevated serial serum sCD30, IL10, CCL17, or
CCL22 correlate with relapse/progression or PET scan results.

- To confirm independently useful tissue biomarkers for risk stratification in patients
with non-bulky stage I and II Hodgkin lymphoma treated with these regimens.

- To compare mediastinal bulk on standing PA and lateral chest x-ray (> 0.33 maximum
chest diameter) with chest CT (mass > 10 cm).

OUTLINE: This is a multicenter study.

- ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV over 3-5 minutes,
bleomycin sulfate IV over 3-5 minutes, 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.
Patients then undergo PET scan. Patients achieving complete response (CR), partial
response (PR), or stable disease (SD) with a negative PET scan receive 2 additional
courses of ABVD chemotherapy in the absence of disease progression or unacceptable
toxicity. Patients achieving CR, PR, or SD with a positive PET scan proceed to
escalated BEACOPP chemotherapy.

- Escalated BEACOPP* chemotherapy: Patients receive doxorubicin hydrochloride IV over 3-5
minutes and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 45-60
minutes on days 1-3, oral procarbazine on days 1-7, oral prednisone on days 1-14, and
bleomycin sulfate IV and vincristine IV on day 8. Treatment repeats every 21 days for 2
courses in the absence of disease progression or unacceptable toxicity. Within 4-6
weeks after completion of BEACOPP chemotherapy, patients undergo involved-field
radiotherapy (IFRT) 5 days a week for 3½ weeks.

NOTE: * HIV-positive patients receive standard BEACOPP instead of escalated BEACOPP.

Patients undergo fludeoxyglucose F^18 PET/CT scan at baseline, and within 8-10 days after
completion of chemotherapy. Patients also undergo additional PET/CT scans within 3-4 weeks
after completion of ABVD or within 12 weeks after completion of BEACOPP and IFRT. Patients
with a negative PET scan proceed to follow up. Patients with a positive PET scan undergo
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 biopsy is neither clinically appropriate nor medically feasible
proceed to follow-up. Patients for whom biopsy is neither clinically indicated nor medically
appropriate undergo a repeat PET/CT scan after 3 months. If PET/CT scan remains positive,
patients undergo biopsy as above.

Patients may undergo blood sample collection for biomarker studies.

After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for 2-3 years, and then annually for a maximum of 5 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) at 36 months

Safety Issue:

No

Principal Investigator

David J. Straus, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

Unspecified

Study ID:

CDR0000672913

NCT ID:

NCT01132807

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • adult favorable prognosis Hodgkin lymphoma
  • adult lymphocyte depletion Hodgkin lymphoma
  • adult lymphocyte predominant Hodgkin lymphoma
  • adult mixed cellularity Hodgkin lymphoma
  • adult unfavorable prognosis Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
CCOP - DuluthDuluth, Minnesota  55805
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Harrington Cancer CenterAmarillo, Texas  79106
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Yale Cancer CenterNew Haven, Connecticut  06520-8028
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Iredell Memorial HospitalStatesville, North Carolina  28677
St. Charles Mercy HospitalOregon, Ohio  43616
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Mountainview MedicalBerlin, Vermont  05602
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Evanston HospitalEvanston, Illinois  60201-1781
McFarland Clinic, PCAmes, Iowa  50010
Billings Clinic - DowntownBillings, Montana  59107-7000
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Diagnostic and Treatment CenterWeston, Wisconsin  54476
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Union Hospital of Cecil CountyElkton MD, Maryland  21921
West Tennessee Cancer Center at Jackson-Madison County General HospitalJackson, Tennessee  38301
Louisville Oncology at Norton Cancer Institute - LouisvilleLouisville, Kentucky  40202
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Mount Sinai Hospital Medical CenterChicago, Illinois  60608
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Castle Medical CenterKailua, Hawaii  96734
Kauai Medical ClinicLihue, Hawaii  96766
Norton Suburban HospitalLouisville, Kentucky  40207
Kuakini Medical CenterHonolulu, Hawaii  96817
Oncare Hawaii, Incorporated - Pali MomiAiea, Hawaii  96701