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
Springfield, Missouri 65807
1400
mi
from 91732
Springfield, MO
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
567
mi
from 91732
Salt Lake City, UT
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Albuquerque, New Mexico 87109
654
mi
from 91732
Albuquerque, NM
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
2275
mi
from 91732
Bethesda, MD
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Bridgeport, Connecticut 06606
2473
mi
from 91732
Bridgeport, CT
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Bridgeton, Missouri 63044
1560
mi
from 91732
Bridgeton, MO
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Dallas, Texas 75390
1221
mi
from 91732
Dallas, TX
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Dublin, Georgia 31021
2020
mi
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Dublin, GA
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Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
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Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
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Gettysburg, Pennsylvania 17325
2266
mi
from 91732
Gettysburg, PA
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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...
2430
mi
from 91732
Hackensack, NJ
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Laguna Hills, California 92653
37
mi
from 91732
Laguna Hills, CA
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Laguna Hills, California 92653
37
mi
from 91732
Laguna Hills, CA
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Los Angeles, California 90027
16
mi
from 91732
Los Angeles, CA
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Los Angeles, California 90603
8
mi
from 91732
Los Angeles, CA
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1886
mi
from 91732
Middletown, OH
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Mountain View, California 94040
322
mi
from 91732
Mountain View, CA
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Oklahoma City, Oklahoma 73104
1165
mi
from 91732
Oklahoma City, OK
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Port Charlotte, Florida 33952
2180
mi
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Port Charlotte, FL
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Salinas, California 93901
272
mi
from 91732
Salinas, CA
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Santa Rosa, California 95403
402
mi
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Santa Rosa, CA
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Wellington, Florida 33414
2296
mi
from 91732
Wellington, FL
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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...
1182
mi
from 91732
Wichita, KS
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