Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor

NCT00003211 | Completed Phase 2

• 4 other identifiers: CDR0000066069SJCRH-MB-96SJMB-96NCI-G98-1387
• Study Type: interventional
• Target: 94
• Locations: 2 countries
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy or radiation therapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy with topotecan, cyclophosphamide, cisplatin, and vincristine plus radiation therapy and peripheral stem cell transplantation in treating children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood supratentorial primitive neuroectodermal tumor; untreated childhood medulloblastoma

Study Arms (2)

Average-risk

EXPERIMENTAL

Participants meeting the eligibility requirements for assignment to the average-risk arm. Interventions: filgrastim, amifostine trihydrate, cisplatin, cyclophosphamide, vincristine sulfate, peripheral blood stem cell transplantation, radiation therapy.

Biological: filgrastim; Drug: amifostine trihydrate; Drug: cisplatin; Drug: cyclophosphamide; Drug: vincristine sulfate; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy

High-risk

EXPERIMENTAL

Participants meeting the eligibility requirements for assignment to the high-risk arm. Interventions: filgrastim, amifostine trihydrate, cisplatin, cyclophosphamide, vincristine sulfate, peripheral blood stem cell transplantation, radiation therapy.

Biological: filgrastim; Drug: amifostine trihydrate; Drug: cisplatin; Drug: cyclophosphamide; Drug: vincristine sulfate; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Average-risk; High-risk

amifostine trihydrate DRUG

Average-risk; High-risk

cisplatin DRUG

Average-risk; High-risk

cyclophosphamide DRUG

Average-risk; High-risk

vincristine sulfate DRUG

Average-risk; High-risk

peripheral blood stem cell transplantation PROCEDURE

Also known as: PBSCT

Average-risk; High-risk

radiation therapy RADIATION

Average-risk; High-risk

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically proven medulloblastoma or supratentorial primitive neuroectodermal tumor * Average-risk group: * Localized tumor with no overt evidence of invasion beyond the posterior fossa * Less than 1.5 cm2 residual tumor/imaging abnormality * No CNS or extraneural metastasis (confirmed by bone scan) * Brain stem invasion allowed if above criteria met * High-risk group: * Metastatic disease within the neuraxis (subarachnoid dissemination) OR greater than 1.5 cm\^2 residual disease at the primary site after surgery * No bone involvement by bone scan * Must begin study within 28 days of definitive surgery PATIENT CHARACTERISTICS: Age * 3 to 20 at diagnosis Performance status * ECOG 0-3 (except patients with posterior fossa syndrome) Life expectancy * Not specified Hematopoietic * WBC greater than 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic * Bilirubin less than 1.5 mg/dL * SGPT less than 1.5 times normal Renal * Creatinine less than 1.2 mg/dL OR * Creatinine clearance greater than 70 mL/min Other * Not pregnant or nursing * Negative pregnancy test * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Prior corticosteroids allowed Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Related Publications (2)

• Laughton SJ, Merchant TE, Sklar CA, Kun LE, Fouladi M, Broniscer A, Morris EB, Sanders RP, Krasin MJ, Shelso J, Xiong Z, Wallace D, Gajjar A. Endocrine outcomes for children with embryonal brain tumors after risk-adapted craniospinal and conformal primary-site irradiation and high-dose chemotherapy with stem-cell rescue on the SJMB-96 trial. J Clin Oncol. 2008 Mar 1;26(7):1112-8. doi: 10.1200/JCO.2008.13.5293.

  PMID: 18309946 RESULT

• Gajjar A, Chintagumpala M, Ashley D, Kellie S, Kun LE, Merchant TE, Woo S, Wheeler G, Ahern V, Krasin MJ, Fouladi M, Broniscer A, Krance R, Hale GA, Stewart CF, Dauser R, Sanford RA, Fuller C, Lau C, Boyett JM, Wallace D, Gilbertson RJ. Risk-adapted craniospinal radiotherapy followed by high-dose chemotherapy and stem-cell rescue in children with newly diagnosed medulloblastoma (St Jude Medulloblastoma-96): long-term results from a prospective, multicentre trial. Lancet Oncol. 2006 Oct;7(10):813-20. doi: 10.1016/S1470-2045(06)70867-1.

  PMID: 17012043 RESULT

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Filgrastim; Amifostine; Cisplatin; Cyclophosphamide; Vincristine; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Amar Gajjar, MD

  St. Jude Children's Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 9, 2003
• Study Start: October 1, 1996
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

AU (2); US (2)