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Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical 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); ABVD regimen (Drug); BEACOPP regimen (Drug); cyclophosphamide (Drug); dacarbazine (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); prednisone (Drug); procarbazine hydrochloride (Drug); vinblastine sulfate (Drug); vincristine sulfate (Drug); laboratory biomarker analysis (Other); computed tomography (Procedure); fludeoxyglucose F 18 (Radiation); radiation therapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Cancer and Leukemia Group B

Official(s) and/or principal investigator(s):
Ann S. LaCasce, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

Clinical Details

Official title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL)

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

Primary outcome: Progression-free survival at 36 months from enrollment

Secondary outcome:

Complete response rate

Standard uptake values (SUVs) for target sites measured at baseline, after course 2, and after completion of therapy

Determination of the optimal cutoff for absolute decrease in maximum SUV body weight (SUVbw) and SUV lean body mass (SUVlbm), relative uptake in tumor vs various reference anatomic sites, IHP criteria as well as various cutoffs for post-therapy maxim ...

Volumetric vs 2-dimensional (2-D) measurement changes for target lesions between baseline and after course 2, at the end of chemotherapy, and after IFRT

Comparison of qualitative and semiquantitative fludeoxyglucose-PET findings/changes, 2-D and volumetric CT changes, and combinatorial analyses (PET + dedicated CT data) with molecular parameters and conventional parameters

Detailed description: 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

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

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

Locations and Contacts

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States; Recruiting
Clinical Trial Office - CCOP - Christiana Care Health Services, Phone: 302-623-4450

MedStar Georgetown University Hospital, Washington, District of Columbia 20007, United States; Recruiting
Bruce Cheson, Phone: 202-444-7932

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States; Recruiting
Clinical Trials Office - University of Chicago Cancer Research, Phone: 773-834-7424

Evanston Hospital, Evanston, Illinois 60201-1781, United States; Recruiting
Clinical Trials Office - Evanston Hospital, Phone: 847-570-1381

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland 21201, United States; Recruiting
Clinical Trials Office - Greenebaum Cancer Center at Universit, Phone: 800-888-8823

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Ann S. LaCasce, MD, Phone: 617-632-5959

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Clinical Trials Office - Massachusetts General Hospital, Phone: 877-726-5130

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri 63110, United States; Recruiting
Nancy L. Bartlett, MD, Phone: 314-362-5654

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Nancy Bartlett, Phone: 314-362-5654

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-6805, United States; Recruiting
Clinical Trials Office - UNMC Eppley Cancer Center at the Univ, Phone: 800-999-5465

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756-0002, United States; Recruiting
Clinical Trials Office - Norris Cotton Cancer Center, Phone: 603-650-7609, Email: cancerhelp@dartmouth.edu

New York Weill Cornell Cancer Center at Cornell University, New York, New York 10021, United States; Recruiting
Clinical Trials Office - New York Weill Cornell Cancer Center, Phone: 212-746-1848

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States; Recruiting
Clinical Trials Office - SUNY Upstate Medical University Hospi, Phone: 315-464-5476

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States; Recruiting
Clinical Trials Office - Blumenthal Cancer Center at Carolinas, Phone: 704-355-2884

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina 28206, United States; Recruiting
David Miller, Phone: 980-442-5221

Presbyterian Hospital, Charlotte, North Carolina 28204, United States; Recruiting
Mark Mogul, Phone: 304-399-6503

Batte Cancer Center at Northeast Medical Center, Concord, North Carolina 28025, United States; Recruiting
David W. Miller, MD, Phone: 704-302-8300

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States; Recruiting
James N. Atkins, MD, Phone: 919-580-0000

Iredell Memorial Hospital, Statesville, North Carolina 28677, United States; Recruiting
Ruby Grimm, Phone: 704-873-2219

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
David Hurd, Phone: 336-716-2088

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210-1240, United States; Recruiting
Ohio State University Cancer Clinical Trial Matching Service, Phone: 866-627-7616, Email: Jamesline@osumc.edu

Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont 05602, United States; Recruiting
Emiliano Mugnaini, Phone: 802-656-5487

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont 05401, United States; Recruiting
Clinical Trials Office - Fletcher Allen Health Care, Phone: 802-656-8990

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia 23298-0037, United States; Recruiting
Clinical Trials Office -Virginia Commonwealth University Masse, Phone: 804-628-1939

Additional Information

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

Starting date: September 2010
Last updated: October 7, 2013

Page last updated: August 23, 2015

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