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Phase II Study of Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP) as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma


Phase 2
N/A
3 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase II Study of Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP) as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma


OBJECTIVES: I. Determine the efficacy of high-dose methotrexate (HMTX) in combination with
mechlorethamine, vincristine, prednisone, and procarbazine (MOPP) in infants or young
children with primitive neuroectodermal tumors (PNET) (including medulloblastoma, anaplastic
ependymoma, ependymoblastoma, or pineoblastoma) or high-grade astrocytoma. II. Determine
whether the addition of HMTX to MOPP (MMOPP) improves the continuous complete response rate
of MOPP alone and eliminates the need for salvage with radiotherapy in these patients. III.
Determine the ability of MMOPP to provide neuroaxis prophylaxis or to treat spinal
metastasis without radiotherapy in infants or young children with PNET. IV. Determine the
toxicity of this regimen in terms of neurologic and neuropsychologic sequelae, growth, and
development in these patients. V. Correlate the efficacy of this regimen with the
histopathologic diagnosis of these patients. VI. Determine the optimum method for
radiographic evaluation of spinal cord disease in patients with PNET. VII. Determine the
utility of sequential spinal cord radiography as a means of monitoring PNET in these
patients.

OUTLINE: Patients undergo maximum tumor debulking. Patients who have undergone incomplete
resection proceed to induction. Patients with a primary diagnosis of primitive
neuroectodermal and pineal tumors or glioblastoma multiforme who have undergone total
resection proceed to induction. Induction: Patients receive high dose methotrexate (HMTX) IV
over 6 hours on day 1. Beginning 3 hours after completion of HMTX infusion, leucovorin
calcium (CF) is administered IV over 30 minutes every 3 hours for 9 doses. Beginning 3 hours
after completion of the last CF infusion, oral CF is administered every 6 hours for 8 doses.
Patients receive a second HMTX infusion beginning 1 week after completion of the first HMTX
infusion. Beginning 1 week after completion of the second HMTX infusion, patients receive
mechlorethamine IV and vincristine IV on days 1 and 8, oral procarbazine and oral prednisone
on days 1-10, and tapered doses of prednisone on days 11-13 (MOPP). Maintenance: Beginning 4
weeks after initiating the first course of MOPP, patients receive HMTX on day 1 and MOPP
beginning on day 4. Treatment continues every 31 days in the absence of disease progression
or unacceptable toxicity. After 1 year or 14 doses of HMTX, whichever occurs first, HMTX is
discontinued and treatment with MOPP alone continues every 4 weeks in the absence of disease
progression or unacceptable toxicity. Treatment is discontinued after 2 years if the patient
is in continuous complete remission.

PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study within 24-30
months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patient with Overall Response

Outcome Time Frame:

Every 31 days

Safety Issue:

No

Principal Investigator

Joann Ater, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

P88-006

NCT ID:

NCT00002463

Start Date:

February 1989

Completion Date:

January 2008

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood infratentorial ependymoma
  • childhood low-grade cerebral astrocytoma
  • childhood low-grade cerebellar astrocytoma
  • childhood supratentorial ependymoma
  • childhood high-grade cerebral astrocytoma
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • untreated childhood cerebellar astrocytoma
  • untreated childhood medulloblastoma
  • untreated childhood visual pathway and hypothalamic glioma
  • newly diagnosed childhood ependymoma
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009