Non Hodgkin Lymphoma Clinical Trial
Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
Summary
This clinical trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more cancer cells.
Full Description
PRIMARY OBJECTIVES:
I. To preserve the excellent cure rate in patients with lymphocyte predominant Hodgkin disease (LPHD) while employing a treatment strategy that minimizes the exposure to chemotherapy and radiation therapy in appropriate patients.
II. To estimate the proportion of stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.
III. To estimate the proportions of stage I unresected, stage I resected (whose disease has recurred after observation), and stage II LPHD patients who can be cured with adriamycin (doxorubicin)/vincristine/prednisone/cyclophosphamide (AV-PC) x 3, with involved field radiation therapy (IFRT) for those who are not in a CR after chemotherapy.
IV. To reduce the potential for long-term toxicity of LPHD treatment.
OUTLINE: This is a pilot study.
Patients with stage IA disease who underwent confirmed complete resection of a single involved lymph node at diagnosis undergo observation only*.
Patients with stage IA disease who underwent possible complete resection of a single involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not demonstrate complete resection by imaging proceed to combination chemotherapy with or without radiotherapy.
Patients with stage IA disease who underwent a fine needle aspiration of a single involved lymph node OR an incomplete resection of a single involved lymph node at diagnosis may undergo a second surgery to achieve complete resection. Patients who undergo complete resection during the second surgery undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not undergo a second surgery OR do not achieve complete resection with the second surgery proceed to combination chemotherapy with or without radiotherapy. Patients with stage IA disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to combination chemotherapy with or without radiotherapy.
NOTE: *Patients with recurrent disease after observation only undergo biopsy and restaging and then proceed to combination chemotherapy with or without radiotherapy. (AS OF AMENDMENT #4, THE TREATMENT ARM FOR PATIENTS WHOSE CANCER RECURRED AFTER OBSERVATION ALONE IS NOW CLOSED)
COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (IV) over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on days 1 and 8, and prednisone orally (PO) or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiotherapy.
INVOLVED-FIELD RADIOTHERAPY (IFRT): Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, annually for 5 years, and then every 5 years for 10 years.
Eligibility Criteria
Inclusion Criteria:
Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD) are eligible for this protocol as follows:
Diagnosis of LPHD must be made using the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification criteria and will be confirmed by rapid pathology central review
Clinical stages as follows:
Stage IA without bulk disease
Stage IIA without bulk disease
Patients with "B" symptoms or bulk disease are NOT eligible for this study
Slides for rapid central pathology review must be sent to the Biopathology Center (BPC)
Serum glutamic oxalo-acetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times ULN
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min
Creatinine based on age/gender as follows:
No greater than 0.4 mg/dL (for patients 1 to 5 months of age)
No greater than 0.5 mg/dL (for patients 6 to 11 months of age)
No greater than 0.6 mg/dL (for patients 1 year of age)
No greater than 0.8 mg/dL (for patients 2 to 5 years of age)
No greater than 1.0 mg/dL (for patients 6 to 9 years of age)
No greater than 1.2 mg/dL (for patients 10 to 12 years of age)
No greater than 1.4 mg/dL (for female patients >= 13 years of age)
No greater than 1.5 mg/dL (for male patients 13 to 15 years of age)
No greater than 1.7 mg/dL (for male patients >= 16 years of age)
Shortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by multigated radionuclide angiogram (MUGA)
Lactating females must agree that they will not breastfeed a child if they are to receive chemotherapy or radiation treatment*
Female patients of childbearing potential must have a negative pregnancy test if they are to receive chemotherapy or radiation treatment*
Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method if they are to receive chemotherapy or radiation treatment*
Note: *Pregnant or breastfeeding women with stage I, single involved lymph node and confirmed (by Quality Assurance Review Center [QARC ]) total resection, are eligible for the observation arm only; no chemotherapy or radiation treatment will be administered to pregnant or breastfeeding women
No prior chemotherapy
More than 30 days since prior systemic corticosteroids
No prior radiotherapy
All patients and/or their parents or legal guardians must sign a written informed consent
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There are 157 Locations for this study
Birmingham Alabama, 35233, United States
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85016, United States
Tucson Arizona, 85719, United States
Little Rock Arkansas, 72202, United States
Little Rock Arkansas, 72205, United States
Downey California, 90242, United States
Duarte California, 91010, United States
Long Beach California, 90806, United States
Los Angeles California, 90027, United States
Oakland California, 94609, United States
Oakland California, 94611, United States
Orange California, 92868, United States
Sacramento California, 95816, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
San Francisco California, 94143, United States
Torrance California, 90502, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80218, United States
Farmington Connecticut, 06030, United States
Hartford Connecticut, 06106, United States
New Haven Connecticut, 06520, United States
Wilmington Delaware, 19803, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20010, United States
Fort Myers Florida, 33901, United States
Gainesville Florida, 32610, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Orlando Florida, 32803, United States
Orlando Florida, 32806, United States
Orlando Florida, 32806, United States
Orlando Florida, 32806, United States
Orlando Florida, 32827, United States
Pensacola Florida, 32504, United States
Saint Petersburg Florida, 33701, United States
Tampa Florida, 33607, United States
West Palm Beach Florida, 33407, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30322, United States
Savannah Georgia, 31404, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96826, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Oak Lawn Illinois, 60453, United States
Park Ridge Illinois, 60068, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61637, United States
Springfield Illinois, 62702, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
Bangor Maine, 04401, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21287, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
East Lansing Michigan, 48824, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49008, United States
Minneapolis Minnesota, 55404, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64108, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68198, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07960, United States
New Brunswick New Jersey, 08901, United States
New Brunswick New Jersey, 08903, United States
Paterson New Jersey, 07503, United States
Summit New Jersey, 07902, United States
Albuquerque New Mexico, 87102, United States
Albany New York, 12208, United States
Bronx New York, 10467, United States
Brooklyn New York, 11201, United States
Buffalo New York, 14263, United States
New Hyde Park New York, 11040, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Syracuse New York, 13210, United States
Valhalla New York, 10595, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27834, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44308, United States
Cincinnati Ohio, 45229, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43205, United States
Dayton Ohio, 45404, United States
Toledo Ohio, 43606, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97227, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Hershey Pennsylvania, 17033, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15224, United States
Providence Rhode Island, 02903, United States
Columbia South Carolina, 29203, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Sioux Falls South Dakota, 57117, United States
Chattanooga Tennessee, 37403, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37232, United States
Amarillo Texas, 79106, United States
Austin Texas, 78723, United States
Corpus Christi Texas, 78411, United States
Dallas Texas, 75230, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84113, United States
Burlington Vermont, 05405, United States
Falls Church Virginia, 22042, United States
Norfolk Virginia, 23507, United States
Seattle Washington, 98105, United States
Spokane Washington, 99204, United States
Charleston West Virginia, 25304, United States
Huntington West Virginia, 25701, United States
Milwaukee Wisconsin, 53226, United States
Westmead New South Wales, 2145, Australia
Westmead New South Wales, 2145, Australia
Herston Queensland, 4029, Australia
North Adelaide South Australia, 5006, Australia
Perth Western Australia, 6008, Australia
Calgary Alberta, T3B 6, Canada
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V6H 3, Canada
Winnipeg Manitoba, R3E 0, Canada
Saint John's Newfoundland and Labrador, A1B 3, Canada
Halifax Nova Scotia, B3K 6, Canada
Hamilton Ontario, L8N 3, Canada
Kingston Ontario, K7L 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Quebec , G1V 4, Canada
Petah Tikua , 49202, Israel
Grafton Auckland, 1145, New Zealand
Christchurch , 8011, New Zealand
San Juan , 00912, Puerto Rico
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