NCT00002463

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of methotrexate, mechlorethamine, vincristine, procarbazine, and prednisone in treating children with astrocytomas or primitive neuroectodermal tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 1989

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1989

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

17.9 years

First QC Date

November 1, 1999

Last Update Submit

February 14, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymomachildhood low-grade cerebral astrocytomachildhood low-grade cerebellar astrocytomachildhood supratentorial ependymomachildhood high-grade cerebral astrocytomauntreated childhood supratentorial primitive neuroectodermal tumoruntreated childhood cerebellar astrocytomauntreated childhood medulloblastomauntreated childhood visual pathway and hypothalamic gliomanewly diagnosed childhood ependymoma

Outcome Measures

Primary Outcomes (1)

  • Number of Patient with Overall Response

    Every 31 days

Study Arms (1)

Combination Chemotherapy

EXPERIMENTAL

Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine

Drug: MOPP RegimenDrug: Leucovorin CalciumDrug: Mechlorethamine HydrochlorideDrug: MethotrexateDrug: PrednisoneDrug: Procarbazine HydrochlorideDrug: Vincristine SulfateProcedure: Conventional Surgery

Interventions

MOPP RegimenDRUG

Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP)

Combination Chemotherapy
Leucovorin CalciumDRUG
Combination Chemotherapy
Mechlorethamine HydrochlorideDRUG
Combination Chemotherapy
MethotrexateDRUG
Combination Chemotherapy
PrednisoneDRUG
Combination Chemotherapy
Procarbazine HydrochlorideDRUG
Combination Chemotherapy
Vincristine SulfateDRUG
Combination Chemotherapy
Conventional SurgeryPROCEDURE
Combination Chemotherapy

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
DISEASE CHARACTERISTICS: Histologically proven previously untreated (except surgically) primitive neuroectodermal tumors (including medulloblastoma, anaplastic ependymoma, ependymoblastoma, or pineoblastoma) or high-grade astrocytomas Low-grade astrocytomas or optic tract tumors that are incompletely resected and have a progressive course not amenable to further surgery may also be allowed Evaluable disease by MRI, CT scan, or CT myelography PATIENT CHARACTERISTICS: Age: Under 4 years Performance status: Not specified Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 90 IU/dL Renal: Creatinine clearance greater than 80 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) No prior high-dose methotrexate No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: Recovered from acute toxic effects of any prior therapy Must be on a tyramine-free diet during procarbazine administration

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

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (2)

  • Ater J, Worth L, Bruner J, et al.: Young children treated with MOPP or methotrexate-MOP for medulloblastoma: identification of a subset of patients with good prognosis. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-1397, 1995.

    RESULT

  • Ater JL, van Eys J, Yung WK, et al.: Response to methotrexate, mechlorethamine, vincristine, procarbazine, and prednizone (MMOPP) for brain tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 10: A-370, 125, 1991.

    RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytoma

Interventions

MOPP protocolLeucovorinMechlorethamineMethotrexatePrednisoneProcarbazineVincristine

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsAminopterinPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesIndolizidinesIndolizines

Study Officials

  • Joann Ater, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 22, 2004

Study Start

February 1, 1989

Primary Completion

January 1, 2007

Study Completion

January 1, 2008

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(1)