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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002463 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: MOPP Regimen Drug: Leucovorin Calcium Drug: Mechlorethamine Hydrochloride Drug: Methotrexate Drug: Prednisone Drug: Procarbazine Hydrochloride Drug: Vincristine Sulfate Procedure: Conventional Surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 4 |
| Study Start Date: | February 1989 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | May 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Combination Chemotherapy |
Drug: MOPP Regimen
Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP)
Drug: Leucovorin Calcium
Drug: Mechlorethamine Hydrochloride
Drug: Methotrexate
Drug: Prednisone
Drug: Procarbazine Hydrochloride
Drug: Vincristine Sulfate
Procedure: Conventional Surgery
|
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.
Eligibility| Ages Eligible for Study: | up to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Joann Ater, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Joann Ater, MD / Professor, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002463 History of Changes |
| Other Study ID Numbers: | P88-006, P30CA016672, MDA-P-88006, NCI-V89-0125, CDR0000075917 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 2, 2010 |
| Health Authority: | United States: Federal Government |
|
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 Glioma Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Mechlorethamine |
Methotrexate Prednisone Procarbazine Vincristine Leucovorin Levoleucovorin Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients |
