Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor

NCT00006461 | Completed Phase 3 DMC

• 6 other identifiers: P9934NCI-2012-02362CDR0000068269POG-P9934COG-P9934U10CA098543
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use 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 more than one drug and combining chemotherapy with surgery and radiation therapy may kill more tumor cells.

Conditions

Untreated Childhood Medulloblastoma; Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

Outcome Measures

Primary Outcomes (1)

• Event-free survival rate

  1 year

Secondary Outcomes (4)

• Acute and chronic toxicities associated with the treatment regimens

  Up to 9 years

• Neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation

  Up to 9 years

• Feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations

  Up to 9 years

• Incidence of atypical teratoid and/or rhabdoid tumor

  Up to 9 years

Study Arms (1)

Chemotherapy, surgery, radiation therapy

OTHER

Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.

Drug: cisplatin; Drug: cyclophosphamide; Drug: vincristine sulfate; Drug: etoposide; Procedure: therapeutic conventional surgery; Radiation: 3-dimensional conformal radiation therapy

Interventions

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Chemotherapy, surgery, radiation therapy

cyclophosphamide DRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Chemotherapy, surgery, radiation therapy

vincristine sulfate DRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS

Chemotherapy, surgery, radiation therapy

etoposide DRUG

Given PO

Also known as: EPEG, VP-16, VP-16-213

Chemotherapy, surgery, radiation therapy

therapeutic conventional surgery PROCEDURE

Undergo surgery

Chemotherapy, surgery, radiation therapy

3-dimensional conformal radiation therapy RADIATION

Undergo 3-dimensional conformal radiation therapy

Also known as: 3D conformal radiation therapy, 3D-CRT

Chemotherapy, surgery, radiation therapy

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Histologically confirmed primary medulloblastoma or posterior fossa primitive neuroectodermal tumor
• Prior definitive tumor resection within 6 weeks of study
• No evidence of metastases
• Hemoglobin at least 10 g/dL
• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• AST less than 2.5 times normal
• Bilirubin less than 1.5 mg/dL
• Creatinine less than 1.2 mg/dL
• Creatinine clearance greater than 70 mL/min
• No prior chemotherapy
• No prior radiotherapy
• See Disease Characteristics

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Interventions

Cisplatin; Cyclophosphamide; Vincristine; Etoposide; Radiotherapy, Conformal

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• David Ashley

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 2000
• Primary Completion: September 1, 2007
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

US (1)