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Status:

TERMINATED

TP-38 Toxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma

Lead Sponsor:

Pediatric Brain Tumor Consortium

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

3-21 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: The TP-38 toxin can locate tumor cells and kill them without harming normal cells. Giving TP-38 toxin directly into the tumor may kill more tumor cells. PURPOSE: This phase I/II trial is s...

Detailed Description

OBJECTIVES: Primary * Phase I * Determine the maximum safe volume rate and maximum tolerated infusion concentration of TGFa-PE38 toxin (TP-38) infused through 2 or 3 catheters in pediatric patien...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed supratentorial malignant glioma
  • Recurrent or progressive disease
  • Amenable to gross total resection, clinically indicated partial resection, or biopsy
  • Tumor must have a single solid portion at least 1 cm and no greater than 5 cm in maximum diameter
  • No tumor crossing midline
  • Tumors invading the corpus callosum that do not extend beyond to midline or into the contralateral hemisphere allowed
  • No more than 1 focus of tumor
  • No tumors involving the brainstem or cerebellum
  • No tumor dissemination (i.e., subependymal or leptomeningeal)
  • Must be on steroids ≥ 3 days prior to surgery
  • Must have received prior external beam radiotherapy (tumor dose at least 45 Gy) and completed therapy at least 8 weeks before study entry
  • No impending herniation, including midline shift greater than 0.5 cm
  • No requirement for immediate palliative treatment
  • PATIENT CHARACTERISTICS:
  • Age
  • 3 to 21
  • Performance status
  • Karnofsky 60-100% (patients over 16 years of age) OR
  • Lansky 60-100% (patients age 16 and under)
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3\*
  • Hemoglobin at least 9 g/dL\* NOTE: \*Transfusion independent
  • Hepatic
  • ALT and AST less than 2.5 times upper limit of normal (ULN)
  • PT and PTT no greater than ULN
  • Renal
  • Creatinine less than 1.5 times normal OR
  • Glomerular filtration rate greater than 70 mL/min
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 30 days after study participation
  • No uncontrolled seizures
  • No active infection requiring treatment
  • No unexplained febrile illness
  • No known or suspected allergies to local anesthetics
  • No systemic disease or other condition that may be associated with unacceptable anesthetic/operative risk and/or that would preclude study completion
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • At least 8 weeks since prior hematopoietic stem cell transplantation
  • Chemotherapy
  • At least 6 months since prior polifeprosan 20 with carmustine implant (Gliadel® wafer)
  • At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas and 2 weeks for vincristine)
  • At least 2 weeks since prior non-cytotoxic chemotherapy
  • No other prior intracerebral chemotherapy
  • No concurrent chemotherapy
  • Endocrine therapy
  • Concurrent steroids allowed
  • Radiotherapy
  • See Disease Characteristics
  • No prior focal radiotherapy (e.g., gamma knife radiosurgery, stereotactic radiosurgery, or brachytherapy)
  • No concurrent radiotherapy
  • Surgery
  • Not specified
  • Other
  • Recovered from prior therapy
  • At least 4 weeks since prior anticancer investigational agents
  • No prior localized antitumor therapy for malignant glioma
  • No other concurrent investigational agent
  • No other concurrent anticancer (including alternative anticancer medicines/treatment) agent or therapy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2006

    Estimated Enrollment :

    3 Patients enrolled

    Trial Details

    Trial ID

    NCT00074334

    Start Date

    May 1 2004

    End Date

    June 1 2006

    Last Update

    October 21 2009

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Children's National Medical Center

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

    2

    Children's Memorial Hospital - Chicago

    Chicago, Illinois, United States, 60614

    3

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    4

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710