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Spots Global Cancer Trial Database for Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

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Trial Identification

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

Conditions

Neuroblastoma

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Susan G. Kreissman, MD

Affiliation: Duke Cancer Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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