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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: Bleomycin Sulfate (Biological); Doxorubicin Hydrochloride (Drug); Procarbazine Hydrochloride (Drug); Vinblastine Sulfate (Drug); Dacarbazine (Drug); Cyclophosphamide (Drug); Etoposide phosphate (Drug); prednisone (Drug); Radiation Therapy (Drug); Fludeoxyglucose F-18 (Radiation); computed tomography (Procedure); Positron Emission Tomography (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
David J. Straus, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center


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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival (PFS) at 36 months

Secondary outcome: complete response rate

Detailed description: PRIMARY OBJECTIVES: I. To determine the progression-free survival (PFS) from enrollment for patients with non-bulky stage I and II Hodgkin lymphoma. II. To compare the PFS of patients who are PET positive versus PET negative following 2 cycles of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD). SECONDARY OBJECTIVES: I. To evaluate the complete response (CR) rate of patients diagnosed with non-bulky stage I and II Hodgkin lymphoma following PET response-adapted chemotherapy with or without radiation therapy. II. To determine the predictive value of fludeoxyglucose (FDG) uptake using various semi-quantitative approaches, at baseline, after 2 cycles of AVBD and at completion of therapy. III. To determine the predictive value of volumetric changes on computed tomography (CT) vs 2-dimensional (2-D) analyses after 2 cycles and 4 cycles and compare with PET parameters with and without combination analyses (PET + dedicated CT data). IV. To compare the predictive value of metabolic parameters/changes that are measured both visually and semi-quantitatively, International Harmonization Project (IHP) criteria, 2-D and volumetric CT changes, molecular parameters, and conventional parameters, including International Prognostic Score (IPS). V. To assess whether elevated baseline circulating markers of inflammation (including soluble cluster of differentiation CD30 [sCD]30, soluble CD 163 [CD163], interleukin-10 (IL10), chemokine (C-C motif) ligand 17 (CCL17), and chemokine (C-C motif) ligand 22 [CCL22]) correlate with clinical response and PFS and PET scan results. VI. To assess whether persistent or recurrent elevated serial circulating markers of inflammation (including soluble CD30 [sCD30], soluble CD163 [sCD163], IL10, CCL17, or CCL22) correlate with relapse/progression or PET scan results. VII. To confirm independently useful tissue biomarkers for risk stratification in patients with non-bulky stage I and II Hodgkin lymphoma treated with this regimen. VIII. To compare mediastinal bulk on standing posterior-anterior (PA) and lateral chest x-ray (> 0. 33 maximum chest diameter) with chest CT (mass > 10 cm). OUTLINE: ABVD CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (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, procarbazine orally (PO) on days 1-7, prednisone PO 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. 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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.



- 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 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

Locations and Contacts

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724-5024, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

Yale Cancer Center, New Haven, Connecticut 06520-8028, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia 20007, United States

M.D. Anderson Cancer Center at Orlando, Orlando, Florida 32806, United States

MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912, United States

Kapiolani Medical Center at Pali Momi, Aiea, Hawaii 96701, United States

Oncare Hawaii, Incorporated - Pali Momi, Aiea, Hawaii 96701, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States

Kuakini Medical Center, Honolulu, Hawaii 96817, United States

OnCare Hawaii, Incorporated - Kuakini, Honolulu, Hawaii 96817-3169, United States

OnCare Hawaii, Incorporated - Lusitana, Honolulu, Hawaii 96813, United States

Queen's Cancer Institute at Queen's Medical Center, Honolulu, Hawaii 96813, United States

Straub Clinic and Hospital, Incorporated, Honolulu, Hawaii 96813, United States

Castle Medical Center, Kailua, Hawaii 96734, United States

Kauai Medical Clinic, Lihue, Hawaii 96766, United States

John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois 60612-3785, United States

Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, United States

Mount Sinai Hospital Medical Center, Chicago, Illinois 60608, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States

Evanston Hospital, Evanston, Illinois 60201-1781, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois 60153, United States

McFarland Clinic, PC, Ames, Iowa 50010, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States

CCOP - Wichita, Wichita, Kansas 67214, United States

Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky 40536-0093, United States

Louisville Oncology at Norton Cancer Institute - Louisville, Louisville, Kentucky 40202, United States

Norton Suburban Hospital, Louisville, Kentucky 40207, United States

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana 70809, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Medical Center of Louisiana - New Orleans, New Orleans, Louisiana 70112, United States

CancerCare of Maine at Eastern Maine Medical Center, Bangor, Maine 04401, United States

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland 21201, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Union Hospital of Cecil County, Elkton MD, Maryland 21921, United States

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts 01655, United States

Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan 49221, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan 48106-0995, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota 55422-2900, United States

Regions Hospital Cancer Care Center, St. Paul, Minnesota 55101, United States

Missouri Baptist Cancer Center, Saint Louis, Missouri 63131, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri 63110, United States

Billings Clinic - Downtown, Billings, Montana 59107-7000, United States

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-6805, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada 89102, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756-0002, United States

Monter Cancer Center of the North Shore-LIJ Health System, Lake Success, New York 11042, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset, New York 11030, United States

Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States

New York Weill Cornell Cancer Center at Cornell University, New York, New York 10021, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina 28233-3549, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States

Iredell Memorial Hospital, Statesville, North Carolina 28677, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States

Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210-1240, United States

St. Charles Mercy Hospital, Oregon, Ohio 43616, United States

Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio 43623, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania 17822-0001, United States

Fox Chase Cancer Center CCOP Research Base, Philadelphia, Pennsylvania 19140, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania 18711, United States

Bon Secours St. Francis Health System, Greenville, South Carolina 29601, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

West Tennessee Cancer Center at Jackson-Madison County General Hospital, Jackson, Tennessee 38301, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States

Harrington Cancer Center, Amarillo, Texas 79106, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States

Mountainview Medical, Berlin, Vermont 05602, United States

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont 05401, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia 23298-0037, United States

University Cancer Center at University of Washington Medical Center, Seattle, Washington 98195, United States

Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia 26506, United States

Center for Cancer Treatment & Prevention at Sacred Heart Hospital, Eau Claire, Wisconsin 54701, United States

Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin 54601, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Saint Joseph's Hospital, Marshfield, Wisconsin 54449, United States

Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin 54548, United States

Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin 54501, United States

Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States

Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin 54481, United States

Diagnostic and Treatment Center, Weston, Wisconsin 54476, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2010
Last updated: July 23, 2015

Page last updated: August 23, 2015

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