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Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Tumors; Central Nervous System Tumors; Neuroblastoma

Intervention: filgrastim (Biological); carboplatin (Drug); cisplatin (Drug); cyclophosphamide (Drug); vincristine sulfate (Drug); adjuvant therapy (Procedure); radiation therapy (Radiation)

Phase: Phase 2

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Regina Jakacki, MD, Study Chair, Affiliation: Children's Hospital of Pittsburgh of UPMC

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors.

Clinical Details

Official title: An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors

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

Primary outcome: Event Free Survival

Secondary outcome: Survival

Detailed description: OBJECTIVES:

- Determine the feasible dose and duration of carboplatin combined with craniospinal and

local radiotherapy and adjuvant chemotherapy in children with newly diagnosed, high-risk CNS embryonal tumors (Phase I completed as of 11-25-03).

- Determine the feasibility of administering cyclophosphamide and vincristine with or

without cisplatin after concurrent carboplatin, vincristine, and radiotherapy in these patients.

- Determine the overall and individual toxicity rates of this regimen in these patients.

- Determine the complete response rate in patients treated with this regimen.

- Obtain preliminary estimates of event-free survival of patients treated with this

regimen.

- Determine the prognostic significance of enhancing tumor after completion of

radiotherapy on event-free survival of these patients. OUTLINE: This is a pilot, dose-escalation study of carboplatin. (Phase I completed as of 11-25-03.) Within 31 days of definitive surgery, all patients receive vincristine IV weekly for 6 weeks and carboplatin IV over 15-20 minutes (after completion of vincristine infusion) 5 days a week for 6 weeks. Patients undergo radiotherapy (1-4 hours after carboplatin infusion) 5 days a week for 6 weeks. Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 12 patients experience dose-limiting toxicity. (Phase I completed as of 11-25-03.) At 6 weeks after completion of radiotherapy, patients are assigned to arm II for adjuvant/maintenance chemotherapy. (Arm I closed to accrual as of 11-25-03.)

- Arm I (closed to accrual as of 11-25-03): Patients receive cyclophosphamide IV over 1

hour on days 0 and 1, vincristine IV on days 0 and 7, and filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 2 and continuing for at least 10 days until blood counts recover.

- Arm II: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2, vincristine

IV on days 0 and 7, cisplatin IV over 6 hours on day 0, and G-CSF IV or SC beginning on day 3 and continuing for at least 10 days until blood counts recover. In both arms, adjuvant/maintenance chemotherapy repeats every 4 weeks for 6 courses. Patients are followed every 3 months for 8 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.

Eligibility

Minimum age: 3 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically proven high-risk CNS embryonal tumors, including:

- Primitive neuroectodermal tumors

- Atypical teratoid/rhabdoid tumor

- Medulloblastoma

- Desmoplastic medulloblastoma

- Ependymoblastoma

- Medullomyoblastoma

- Spongioblastoma

- Spongioblastoma polare

- Primitive polar spongioblastoma

- Neuroepitheliomatous neoplasms

- Medulloepithelioma

- Neuroblastoma

- Pineoblastoma

- No bone marrow involvement or bone metastases

- No M4 disease

- M3 disease must have evidence of tumor on spinal MRI

PATIENT CHARACTERISTICS: Age:

- 3 to 21 at diagnosis

Performance status:

- Not specified

Life expectancy:

- At least 8 weeks

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count at least 100,000/mm^3 (transfusion independent)

- Hemoglobin at least 10. 0 g/dL (packed red blood cell transfusions allowed)

Hepatic:

- Bilirubin less than 1. 5 mg/dL

- SGOT/SGPT less than 2. 5 times normal

Renal:

- Creatinine less than 1. 5 times upper limit of normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- Prior definitive surgery allowed

Locations and Contacts

British Columbia Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada

Long Beach Memorial Medical Center, Long Beach, California 90806, United States

Children's Hospital Los Angeles, Los Angeles, California 90027-0700, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

Children's Hospital of Orange County, Orange, California 92668, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94115-0128, United States

Children's Hospital of Denver, Denver, Colorado 80218, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

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

Indiana University Cancer Center, Indianapolis, Indiana 46202-5265, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0752, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Children's Mercy Hospital, Kansas City, Missouri 64108, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

St. Joseph's Hospital and Medical Center, Paterson, New Jersey 07503, United States

Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

IWK Grace Health Centre, Halifax, Nova Scotia B3J 3G9, Canada

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio 45229-3039, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

Children's Hospital of Columbus, Columbus, Ohio 43205-2696, United States

Doernbecher Children's Hospital, Portland, Oregon 97201-3098, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

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

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, United States

Additional Information

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

Starting date: March 1998
Last updated: August 22, 2013

Page last updated: August 23, 2015

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