Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors

NCT00031928 | Completed Phase 1

• 3 other identifiers: CDR0000069240NCI-90-C-0095KBCM-H-3241
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.

Conditions

Brain and Central Nervous System Tumors

Keywords

leptomeningeal metastases

Interventions

mafosfamide DRUG

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of leukemia or lymphoma with meningeal involvement defined as cerebrospinal fluid cell count at least 5/mm\^3 AND evidence of blast cells on cytospin preparation or by cytology OR * Diagnosis of other solid tumor with meningeal involvement defined as presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scan * Meningeal malignancy must be progressive or refractory to conventional therapy * Meningeal malignancies secondary to an underlying solid tumor are allowed at initial diagnosis provided there is no conventional therapy * No concurrent bone marrow relapse in leukemia or lymphoma patients * No clinical evidence of obstructive hydrocephalus or compartmentalization of the cerebrospinal fluid flow as documented by a radioisotope indium In 111 or technetium Te 99-DTPA flow study * Patients demonstrating restored flow after focal radiotherapy are allowed PATIENT CHARACTERISTICS: Age: * Over 3 Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Not specified Hepatic: * No clinically significant liver function abnormalities Renal: * No clinically significant renal function abnormalities Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * No clinically significant metabolic parameter abnormalities (e.g., electrolytes, calcium, and phosphorus) * No significant systemic illness (e.g., infection) PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy Chemotherapy: * At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine (liposomal)) and recovered * Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions: * No phase I agent * No agent that significantly penetrates the CNS (e.g., high-dose systemic methotrexate (more than 1 g/m\^2), high-dose cytarabine (more than 2 g/m\^2), IV mercaptopurine, fluorouracil, topotecan, or thiotepa) * No agent known to have serious unpredictable CNS side effects Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy * At least 8 weeks since prior craniospinal irradiation * Local radiotherapy for symptomatic or bulky CNS disease must be given prior to induction therapy * No concurrent whole brain or craniospinal irradiation * Concurrent partial brain (e.g., base of brain) or limited-field spinal radiotherapy for asymptomatic bulky (radiographically visible) CNS disease allowed * Total CNS radiotherapy dose must not exceed accepted safe tissue tolerances Surgery: * Not specified Other: * At least 1 week since any prior CNS therapy * At least 7 days since prior intrathecal investigational agent * At least 14 days since prior systemic investigational agent * No other concurrent intrathecal or systemic investigational agent * No other concurrent intrathecal or systemic therapy to treat meningeal malignancy * No other concurrent intrathecal therapy or agent that significantly penetrates the blood-brain barrier * No concurrent agent known to have serious unpredictable CNS side effects

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Neurological Research Center, Inc.

Bennington, Vermont, 05201, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Meningeal Carcinomatosis

Interventions

mafosfamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Susan M. Blaney, MD

  Texas Children's Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Last Updated: April 30, 2015

Record last verified: 2003-11

Locations

US (9)