The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment



Status:Terminated
Conditions:Chronic Pain, Neurology
Therapuetic Areas:Musculoskeletal, Neurology
Healthy:No
Age Range:18 - Any
Updated:11/1/2018
Start Date:July 2012
End Date:February 11, 2015

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A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain

Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of
many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin,
bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in
greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing
is often either decreased or discontinued potentially affecting tumor responsiveness,
prognosis, and survival.

There is an unmet medical need for treatment of cancer patients with chemotherapy induced
neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of
multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic
pain caused by chemotherapy.


Inclusion Criteria:

- If female, not of childbearing potential.

- Patients with documented neuropathic pain

- Cancer Patients who have completed a chemotherapy regimen which included taxanes or
platinums (or both) and have no evidence actively progressive disease. Concurrent
hormonal therapies are allowed

- Patients with stable moderate to severe neuropathic pain

- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of
0 or 1.

- Patients who are able to complete the study-related questionnaires independently in
either English or Spanish.

Exclusion Criteria:

- History of peripheral neuropathy attributed to any cause other than chemotherapy.

- Patients receiving any concurrent agents known to cause peripheral neuropathy within
30 days of Randomization.

- Current use of other therapy (ies), including "alternative" therapies, for treatment
of peripheral neuropathy within 30 days of Randomization (with the exception of
protocol allowed concurrent medications).

- Patients who used controlled release opioids within seven days of baseline period or
who expect to use controlled release opioids at any time from baseline to end of
study.

- Patients with abnormal kidney function.

- Patients with bone metastases.

- Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy
between screening and the end of study visit.

- Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of
Randomization.

- Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as
physostigmine within 30 days of Randomization.

- Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade
(Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine,
vinorelbine and vindesine.

- Current use of tricyclic antidepressant medication, anticonvulsants and monoamine
oxidase inhibitors.

- Patients with current uncontrolled asthma or lung disease.

- Patients with significant heart disease.

- Use of an investigational agent within 30 days prior to screening or is scheduled to
receive an investigational drug other than TTX during the course of the study.

- Females who are pregnant or nursing
We found this trial at
24
sites
6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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Albuquerque, New Mexico 87109
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Bridgeport, Connecticut 06606
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Bridgeton, Missouri 63044
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Dallas, Texas 75390
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Dublin, Georgia 31021
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Fountain Valley, California 92708
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Fountain Valley, California 92708
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Gettysburg, Pennsylvania 17325
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Laguna Hills, California 92653
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Laguna Hills, California 92653
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Los Angeles, California 90027
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Los Angeles, California 90603
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Middletown, OH
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Mountain View, California 94040
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Oklahoma City, Oklahoma 73104
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Port Charlotte, Florida 33952
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Salinas, California 93901
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Santa Rosa, California 95403
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Springfield, Missouri 65807
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Wellington, Florida 33414
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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