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A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose

Not Enrolling
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose


- Determine the effectiveness of carboxypeptidase-G2 rescue in patients who develop life
threatening methotrexate (MTX) neurotoxicity following accidental intrathecal MTX

- Study the CSF pharmacokinetics of MTX following rescue.

OUTLINE: Patients undergo a lumbar puncture as soon as possible after methotrexate overdose
to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5

Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A maximum of 10 patients will be accrued for this study.

Inclusion Criteria


- Patients who received an intrathecal overdose of methotrexate of 100 mg or more



- Any age

Performance status:

- Not specified


- Not specified


- Not specified


- Not specified


- No prior anaphylactic reaction to carboxypeptidase-G2 administration


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- Not specified


- Not specified


- Concurrent therapy allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Brigitte C. Widemann, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Food and Drug Administration

Study ID:




Start Date:

November 1993

Completion Date:

Related Keywords:

  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • unspecified adult solid tumor, protocol specific
  • neurotoxicity
  • Overdose
  • Neurotoxicity Syndromes
  • Neoplasms



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