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Brief Title: Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
Official Title: A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma
Study ID: NCT00004188
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.
Detailed Description: OBJECTIVES: Primary * Compare the event-free survival in patients with newly diagnosed high risk neuroblastoma or ganglioneuroblastoma treated with myeloablative consolidation chemotherapy and autologous purged versus unpurged peripheral blood stem cells (PBSC). * Compare the time to engraftment and CD34 content and tumor content by reverse transcriptase polymerase chain reaction (RT-PCR) of purged versus unpurged PBSC in patients treated with these regimens. * Determine event-free survival of patients treated with dose intensive induction chemotherapy comprising cyclophosphamide, doxorubicin, and vincristine alternating with cisplatin and etoposide. * Determine the toxicity of this dose-intensive induction chemotherapy regimen in these patients. * Evaluate tumor resectability at second look or delayed surgery, response (complete response and very good partial response) at completion of induction therapy, tumor content of peripheral blood and bone marrow, and the comparison of historical data from CCG-3891 induction therapy in these patients. Secondary * Compare the toxicity of this myeloablative consolidation regimen using purged vs unpurged PBSC in these patients. * Determine if event-free survival is predictable by RT-PCR positivity of the stem cell, minimal residual disease in bone marrow and peripheral blood after transplantation by immunocytology, and extent of disease as measured by MIBG after transplantation in patients treated with these regimens. * Evaluate the prognostic impact of tumor biology on event free survival in patients treated with these regimens. * Determine the incidence of relapse in the primary site after radiotherapy and in irradiated versus unirradiated metastatic sites in these patients. * Assess the toxicity and tolerability of maintenance therapy with topotecan and cyclophosphamide after intensive induction therapy in patients who decline or are unable to receive myeloablative therapy. * Determine the health-related quality of life of patients treated with these regimens. * Compare late effects of these regimens on the growth, endocrine, pulmonary, and cardiac function of these patients vs general population standards. * Determine the incidence of second malignant neoplasms in patients treated with these regimens. * Determine the variability of isotretinoin pharmacokinetics and relationship to pharmacogenomic parameters in these patients. * Correlate the isotretinoin pharmacokinetics and pharmacogenomic parameters and/or genetic variations in isotretinoin metabolic enzymes with event-free survival or systemic toxicity in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms for peripheral blood stem cell (PBSC) collection. All patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 0 and 1, doxorubicin IV and vincristine IV continuously over 72 hours on days 0-2, and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 3 and continuing until blood counts recover for courses 1, 2, 4, and 6. Treatment alternates with courses 3 and 5 comprising etoposide IV over 2 hours on days 0-2, cisplatin IV over 1 hour on days 0-3, and G-CSF SC or IV beginning on day 4 and continuing until blood counts recover. Induction chemotherapy repeats every 3 weeks or when blood counts recover in the absence of disease progression or unacceptable toxicity. After course 2 or 3 of induction chemotherapy, patients undergo PBSC collection, either purged or unpurged, depending on randomization. Patients continue on daily G-CSF until cell collection is complete. * Arm I: Patients undergo unpurged PBSC collection until the target cell count is reached. * Arm II: Patients undergo purged PBSC collection until the target cell count is reached. Patients with immunocytology positive PBSC undergo purged autologous bone marrow collection or repeat purged or unpurged PBSC collection depending on individual patient characteristics. All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy. After induction therapy, patients achieving complete response, very good partial response, or partial response receive consolidation therapy comprising melphalan IV on days -7 to -5 followed by carboplatin IV and etoposide IV continuously over days -7 to -4. Patients receive purged or unpurged PBSC infusion or purged autologous bone marrow transplantation on day 0 followed by G-CSF SC or IV beginning 4 hours after completion of transplantation and continuing until blood counts recover. Beginning on day 66, patients receive oral isotretinoin twice daily for 14 days. Isotretinoin therapy repeats every 4 weeks for 6 courses. After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days. Patients not undergoing transplantation or who are ineligible for consolidation therapy receive maintenance therapy comprising cyclophosphamide IV over 30 minutes followed by topotecan IV over 30 minutes on days 0-4. Patients receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. Maintenance therapy repeats every 3 weeks for 3 courses. After completion of maintenance therapy, patients receive radiotherapy as outlined above. Patients then receive oral isotretinoin twice daily for 14 days. Isotretinoin therapy repeats every 4 weeks for 6 courses. Quality of life is assessed at 1\* and 5 years. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter or until disease progression. NOTE: \* Patients under 5 years of age at 1 year are not assessed until 5 years. PROJECTED ACCRUAL: A total of 486 patients will be accrued for this study within 4 years.
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Southern California Permanente Medical Group, Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States
Children's Hospital and Health Center - San Diego, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States
Children's Hospital Cancer Center, Denver, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States
Broward General Medical Center Cancer Center, Ft. Lauderdale, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
All Children's Hospital, St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States
University of Illinois at Chicago Cancer Center, Chicago, Illinois, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan, Ann Arbor, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States
Children's Hospital of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri, United States
Children's Hospital of Omaha, Omaha, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
St. Barnabas Medical Center, Livingston, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
New York Medical College, Valhalla, New York, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Columbus Children's Hospital, Columbus, Ohio, United States
Children's Medical Center - Dayton, Dayton, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
Medical College of Ohio Cancer Institute, Toledo, Ohio, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, United States
Children's Hospital of Austin, Austin, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States
Carilion Cancer Center of Western Virginia, Roanoke, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Alberta Children's Hospital, Calgary, Alberta, Canada
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada
Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Children's Hospital of Western Ontario, London, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Name: Susan G. Kreissman, MD
Affiliation: Duke Cancer Institute
Role: STUDY_CHAIR