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A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer


Phase 2
18 Years
80 Years
Not Enrolling
Both
Peripheral Nervous System Diseases, Chemotherapy-Induced Peripheral Neuropathy

Thank you

Trial Information

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer

Inclusion Criteria


- Patient must have diagnosis of cancer and be receiving or have received chemotherapy
that has resulted in sensory or motor neuropathy.

- Sensory or motor neuropathy must be >/= grade 2 per Common Toxicity Criteria at
baseline.

- In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is
acceptable.

- Patient must have normal hematological cell counts.

- Patient must have a life expectancy of >/= 3 months.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

082-2001-005

NCT ID:

NCT00041795

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Peripheral Nervous System Diseases
  • Chemotherapy-Induced Peripheral Neuropathy
  • Nervous System Diseases
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
NYU Medical CenterNew York, New York  10016
Providence St. Joseph Medical CenterBurbank, California  91505
Providence Holy Cross Medical CenterMission Hills, California  91345