Naltrexone

[vickie h]

My Onc in Santa Barabara just started me on this drug. She has 3 other patients taking it that have had good responses. There are lots of sites to find out more about this drug and breast cancer. Love, Vickie
PS you can get this filled at any compounding pharmacy.....



Protocol for Low-Dose Naltrexone for Cancer

Michael B. Schachter, M.D., CNS, F.A.C.A.M.



Dr. Bernard Bihari of New York City has been using low doses of naltrexone (an opioid-narcotic antagonist) to stimulate immune function in AIDS patients for many years. In 1985, he administered this treatment to an AIDS patient suffering from non-Hodgkin’s lymphoma and was surprised to find that the patient achieved a complete remission. Subsequently, Dr. Bihari followed up on this initial finding and found that a low dose of naltrexone can have a dramatic positive effect on certain other cancers as well.

The treatment probably should be continued for a lifetime, as some patients who obtained complete remission on the treatment, had a recurrence after stopping the naltrexone. Some of these patients were able to obtain a second remission when the medication was restarted.

The treatment seems to work by causing the body to secrete endorphins (metenkephalin and beta-endorphin), which attach to cancers having opiate receptors, shrinking the tumors and inhibiting their growth. Low dose naltrexone may also help cancer patients by up regulating opioid receptors in cancer cells. When metenkephalin and/or beta-endorphins, are attached to cancer cells while they are dividing, it seems to stimulate a process of programmed cell death or apoptosis, thus killing some cancer cells. Low dose naltrexone may also work by so stimulating certain immune system cells that tend to kill cancer cells, including T4 and natural killer cells.

Responses have been seen in cancer patients with a wide variety of cancers. These include: colon cancer, non-Hodgkin’s lymphoma, Hodgkin’s Disease, chronic lymphocytic leukemia, prostate cancer, malignant melanoma, multiple myeloma, neuroblastoma, pancreatic cancer, breast cancer, ovarian cancer, uterine cancer, brain cancer, lung cancer and others.

The protocol is 1.5 to 4.5 mg at bedtime. It must not be a timed-release preparation and should be given at bedtime. Up until recently, Dr. Bihari had routinely used 3 mg, reducing it down to as low as 1.5 mg in the rare patient who experienced a mild sleep disturbance. (Many patients report improved sleeping.) However, recently, he has noted that some patients who did not respond to 3 mg. did respond to 4.5 mg. and has begun to use this dose more frequently. No more than 4.5 mg. must be used. Occasionally, lower doses are necessary. At doses up to 4.5 mg. per day, naltrexone is immune enhancing. At 5 mg. or more daily, it is immune suppressing. The usual, commercial oral preparation of naltrexone is 50 mg; so, the 1.5 to 4.5 mg dose must be made up by a compounding pharmacy. A month’s supply should run about $30. Although there are no known significant side effects to the treatment, in about 1 out of 50 patients, the patient will experience a sleep disturbance. In this case, Dr. Bihari recommends that the pharmacy make up a 100-ml. solution containing naltrexone in distilled water at a concentration of 1 mg/ml. The patient is told to take 1 to 1 ½ ml. at bedtime—possibly working up to 2 ml. or 2 mg.

According to Bihari, a significant minority of cancer patients obtain a positive response to the treatment. A summary of his results, as well as additional information may be found on his website at http://lowdosenaltrexone.org. He reports improvement as early as within a month and remission frequently occurs within 6 months. Some of his patients have been on the program for more than seven years.

He has recently found that the treatment does not seem to work in prostate cancer patients who have received or are receiving some form of hormone manipulation treatment prior to starting the low dose naltrexone. This includes patients who have received Lupron, Casodex, Eulexin, DES, or other drugs designed to reduce testosterone. In addition, patients who have been treated with PC Spes, the herbal preparation with estrogenic effects, do not seem to respond. I believe this finding may have implications for women who have been treated with hormonal manipulation for breast cancer with drugs such as tamoxifen, aromatase inhibitors, or synthetic progestins, such as Megace. More research is needed to determine if this general principle holds up and if so, the reasons for it. On the other hand, the treatment does seem to work in some patients who have received other forms of conventional treatment, such as radiation and/or chemotherapy. I do not know of any other complementary or alternative cancer (CAM) treatment that interferes with the treatment, although this is a possibility. My guess is that most CAM treatments will turn out to be synergistic with low dose naltrexone.

One contraindication to the use of low dose naltrexone is if the patient is receiving opioid narcotics for pain (painkillers, such as codeine, morphine, Demerol or the Duragesic patch). In such a case, the effect of low dose naltrexone is lost and it may interfere with the pain reducing effects of the opioid narcotic. Also, a patient on opioids may experience withdrawal symptoms if he starts the naltrexone treatment. A patient on opioids must be taken off these drugs by tapering them down, prior to beginning low dose naltrexone. Dr. Bihari uses as a substitute one of the anti-inflammatory drugs Celebrex* (up to 200 mg. BID) or Vioxx* (25 mg. twice daily) and possibly, if necessary, Neurontin* (300 mg. TID). These drugs may be taken daily until the pain is hopefully relieved by the naltrexone. Although, the likelihood of GI bleeding is less with these new COX 2 inhibitors (Celebrex* & Vioxx*), patients should be monitored for possible GI bleeding while taking these drugs.

Obviously, Dr. Bihari’s work needs to be confirmed. However, since it is such a safe and inexpensive treatment, I think any patient who has one of the cancers that have previously responded, should be considered for a trial of low-dose naltrexone. It may also be somewhat helpful for patients whose cancers do not contain opiate receptors because of its immune enhancing effects.

One compounding pharmacy that frequently compounds the low-dose naltrexone is Bigelow’s in New York City (414 6th Avenue--between 8th and 9th Streets: Phone Number: 212-533-2700). A second pharmacy that may be used is Hopewell Pharmacy and Compounding Center (1 West Broad Street, Hopewell, New Jersey 08524, Phone number: 1-800-792-6670; FAX: 1-609-466-8222).

[Faith in Him]

Vickie,

I pray that this is just the right drug to kick those mets right out of you.

Tonya

[schoolteacher]

Vickie,

Please let us all know how you are doing taking the Naltrexone. The article was very interesting.

Amelia

[Mary Anne in TX]

I love your onc!!!!! Tell her we thank her for being so thorough and for helping get you on a new track to get you NED. I'll keep prayin' and believin'.....ma

[vickie h]

Thanks everyone! I'll let you know how this works. It takes a bout 4 weeks to see any results (at least) but I am crossing my fingers and praying alot. Much love to you all. PS Feb 10th marked 5 years for me! I could not have done it without you, God, and hope. Vickie

[eric]

Vickie,

Thanks for sharing. Please keep us posted on how you're doing.

Eric

[Midwest Alice]

Vickie, I missed your post till today. Just wanted to tell you how excited I am about this new drug. I'm praying for your healing. God is working through you're life.

[Rich66]

Does anything or anyone mention what other treatments the successful cancer patients were/are on? I mean, was Naltrexone the only treatment attributable to the response?

[Joe]

I currently found one phase II clinical trial for this drug. The study sites are in Minnesota.

Regards
Joe

[StephN]

Hi Ms. Vickie -

Well, this is a new approach that I don't recall mentioned here before. Says it should be taken as long as you live, but seems pretty benign in its side effects.

Since you are hormone negative, this drug could have a couple of ways to discourage your cancer. I assume there is nothing to show that it should not be taken with the Ixempra.

Let us know how your sleep is now that you have taken it for a few days.

[Rich66]

Trials for which cancers?

[vickie h]

Rich and Steph,
This is the one study I could find. There are several sites I have googled (Naltrexone breast cancer) to find out more about it. Since my BC is not hormone positive, I don't fall into the guidelines from this study. My Onc, Julie Taguchi In Santa Barbara is researching this drug currently. She has given it to me to see if it will work with my kind of BC. I have been on it for 5 days now, sleeping great, and one of my skin mets has already started to scab over and heal. I don't know if this is from the naltrexone or the Ixempra yet, but will stay on it until we can decipher whether it is working .


Naltrexone in Treating Women With Metastatic Breast Cancer That Did Not Respond to Hormone Therapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00379197
Purpose
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using naltrexone may fight breast cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the growth of breast cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well naltrexone works in treating women with metastatic breast cancer that did not respond to previous hormone therapy.

Condition Intervention Phase
Breast Cancer
Drug: naltrexone hydrochloride
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer CT Scans Cancer
Drug Information available for: Naltrexone Naltrexone hydrochloride Fluorodeoxyglucose F18
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Naltrexone for the Treatment of Hormone-Refractory, Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
Disease assessment based on change in specific uptake value (SUV) numbers between baseline fludeoxyglucose F 18 (FDG) positron emission tomography (PET)-CT scan, and FDG-PET-CT scan at weeks 4 and 8 [ Designated as safety issue: No ]

Secondary Outcome Measures:
Toxicity and adverse events as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
Median time to event (first time when maximum SUV is higher than that at baseline) within 1 year of study entry [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2006
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:
Primary
Determine the efficacy of naltrexone in women with hormone-refractory, metastatic breast cancer as measured by serial fludeoxyglucose F 18 positron emission tomography-CT scans.
Secondary
Determine the safety of naltrexone in these patients.
Determine the median time to event (first time when maximum specific uptake values is higher than that at baseline) within 1 year of study entry.
OUTLINE: This is an open-label study.
Patients receive oral naltrexone once daily for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 weeks, patients may continue naltrexone off study at the discretion of the physician.
Patients undergo fludeoxyglucose F 18 positron emission tomography-CT scans at baseline, week 4, week 8, and periodically thereafter.
After completion of study treatment, patients are followed for up to 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of metastatic breast cancer
Disease must have progressed despite prior systemic hormonal therapy
Measurable disease
No brain metastases unless stable for 1 month or more after radiation therapy
Hormone receptor-positive disease
PATIENT CHARACTERISTICS:
Female
Pre- or post-menopausal
Karnofsky performance status 80-100%
Absolute neutrophil count ≥ 1,500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 9 g/dL
Bilirubin < 2 times upper limit of normal (ULN)
AST and ALT < 2 times ULN (≤ 5 times ULN if liver has tumor involvement)
Creatinine < 2 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during study and for 3 months after completion of study treatment
No pain uncontrolled with the use of non-narcotic drugs (acetaminophen or nonsteroidal medications)
No history of sensitivity to naltrexone
No acute hepatitis or liver failure
No positive urine screen for opiods
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from prior therapy
No hormonal therapy within the past 2 weeks
No chemotherapy, immunotherapy, or biologic therapy within the past 3 weeks
No short-acting or long-acting opioid medication (including morphine, meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, or tramadol) within the past 10 days
No concurrent immunosuppressive therapy for patients with autoimmune diseases, organ transplant, or other indications
No concurrent surgery or other procedures that will require narcotic analgesics
No concurrent narcotic analgesics for pain
No concurrent short-acting or long-acting opioid medication (including morphine, meperidine, oxycodone, hydromorphone, hydrocodone, fentanyl, or tramadol)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379197

Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Investigators
Principal Investigator: Tufia Haddad, MD Masonic Cancer Center, University of Minnesota
More Infor

[Rich66]

So this study is using Naltrexone alone as monotherapy?
Any promising results from phase 1?

[lexigirl]

Dear Vickie,

I am hopeful that this drug will do the trick to get you back to NED. It sounds like it may already be working! I hope that you continue to do well with it.

Lexi

p.s.
I sure like your new pic. Adorable!!

[vickie h]

Rich,
I haven't gotten the results from the Phase I trials yet, but am pursuing that right now.
Thanks, Lexigirl, Steph, Alice, MA and all the others for your encouragement. It seems that there are many patients being treated with low dose Naltrexone without chemo, or on patients that have been through the whole gamut of chemos and are now searching for something else.
My Onc. is using this among several of her patients to see what the outcome will be with/without the naltrexone. Since I have been on so many chemos, I thought it worth the try. She has me on 4.5 mg, instead of the 3 mg.
I go for chemo on Wed and will see her then. I'll keep you updated on any progress. Also, there arfe many websites that can be googled for Low dose Naltrexone. They have had 3 annual conferences on it to date.
I still have a lot to learn, but thought any info on new therapies should be explored. Much love to you all, Vickie

Low Dose Naltrexone (LDN)

Updated: 06/08/08

Naltrexone is a drug that originally used to help stop cravings in alcoholics. In a regular dose of Naltrexone, endorphins are released. These "feel good" hormones help alcholics overcome their cravings. Endorphins also regulate the immune system and regulate the growth of some cancers. It was discovered almost accidentally that low doses of Naltrexone, can help tumors shrink.

Our original report on LDN spoke of "cures" for cancers. However, that was a bit of an exaggeration. What researchers are now finding that tumors shrink in quite a few cases. A few go into remission. They also found that tumors start to come back when the patient stops the LDN treatments. When LDN is started again, the tumors again begin to shrink and metastases are inhibited.

This being the case, physicians have developed a third model in cancer treatment: long term cancer stabilization.

This isn't entirely a new approach. I've interviewed a physician in Israel who taught his patients to live with cancer. They developed new life styles and outlived, on the average, those who opted for chemo and/or radiation.

With LDN, tumors shrink and and stabilize. Remission might be a possibility, but lives are returned to normal. The best news is that this works for those who've flunked chemo and radiation.

One of the problems with seeking alternatives is that most do it after flunking out of chemo or radiation, or they've just had enough suffering. But now they bring an extra problem to their new therapist. Now that therapist not only has to deal with that patient's cancer, there's an immune system the therapist has to help heal.

Now, with long term stabilization possible, in 65% of cases, LDN shows a lot of promise in keeping people alive long enough to rebuild their immune systems and try complementary treatments that were, in the past, not very successful with those who had used chemotherapy or radiation in the past.

Take the work of Dr Ozell from Turkey. He realized upwards of a 70% success rate in fighting cancers using a water extract of the Nerium Oleander plant. However, he found that for those who had done treatments using chemotherapy or radiation, their chances of recovery were about thirty percent.

Incorporating a long term recovery using LDN might increase the odds of complete recovery in those would eventually try the Oleander once their immune systems have had time to recover. Sadly, we've not found any studies of people using LDN who've gone on to other complementary approaches.

Though, to be certain, people using LDN report a higher quality of life, no side effects. The only problem with this is that now medicine wants to use more chemotherapy and radiation along with LDN. Go figger.

In large dosages, Naltrexone can damage the liver, however, for cancer therapy, only 3 mg are given at bedtime. At this dosage Naltrexone is nontoxic with no side effects.

Increasing the body's endorphins also activates the immune system's natural killer cells which protects the body against new cancers and keeps malignant cells from metastasizing. Since of Dec, 1999, Dr Bihari, who has a private practice in Manhattan, has been helping to restore natural immune defenses that have been damaged through chemotherapy and radiation.

(2/3/2001): Dr. Bihari is in frequent conversation with the National Cancer Institute in Bethesda and is shipping them detailed summaries and materials (CT scans, MRI's, X-rays, and original pathology slides) on over a dozen patients with marked regressions and/or remissions in a variety of advanced cancers that had failed other therapies but that clearly responded to Low Dose Naltrexone. He should be visiting there and presenting the info to a group of NIH'ers in about 2-3 months. To keep up on the progress of this therapy, visit www.lowdosenaltrexone.org.

(2/13/2001): Dr Bihari has responded to a few questions that we will point out here: LDN is and has been used in conjunction with standard treatments, and has been used as the sole treatment. However, they've had some good results using LDN in conjunction with chemotherapy to avoid some of the side effects of chemotherapy.

From his site, we get the following side note: Hypericin and LDN for Hepatitis C : Over 60 patients have been successfully treated for hepatitis C in Dr. Bihari's practice. In a study of St. John's Wort in 15 patients with HIV in 1990, he had accidentally discovered a significant benefit to liver function in two patients with hepatitis B (whereas there was no improvement in HIV markers). Bihari then began to use St. John's Wort in his private practice to treat hepatitis B and hepatitis C - patients with the former responded well, the latter not at all. Since 1995, Dr. Bihari has been able to use a very highly concentrated form of hypericin, the active ingredient found in St. John's Wort, called HY2 [manufactured by Pacific Biologic in Clayton, CA; 800-869-8783] in the treatment of people with hepatitis C. It is given along with LDN, to enhance the immune response, and in many cases with ribavirin, an antiviral.

There are three possible mechanisms by which low dose Naltrexone (LDN) might exert its effects on tumor growth:

by inducing an increase in metenkephalin (an endorphin produced in large amounts in the adrenal medulla) and beta endorphin in the body;
by increasing the number and density of opiate receptors on the tumor cell membranes, thus making them more responsive endorphins mentioned in 1;
by increasing the natural killer (NK) cell numbers and NK cell activity and CD8 numbers
The cancers Dr Bihari has found that respond to LDN are, Pancreatic Cancer, Breast Cancer, Prostate Cancer, Multiple Myeloma, Malignant Melanoma, Ovarian Cancer, Lymphocytic Leukemia, Colon and Rectal Cancers, Neuroblastoma, Carcinoid, and both Hodgkin's and Non-Hodgkins Lymphoma.

Other diseases for which LDN has shown beneficial effects: Behcet's Disease, Chronic Fatigue Syndrome, HIV/AIDS, Multiple Sclerosis, Psoriasis, Hepatitis C, Rheumatoid Arthritis, and Systemic Lupus.

We've been informed by a handful of people with MS that LDN has made their lives livable.

Now, here's the funny part. Naltrexone is an FDA approved drug that has passed all its toxicity tests, etc., etc.; but has not been approved for cancer therapy, or any of the other disorders listed above.

Big deal. It is perfectly legal and ethical for a physician to prescribe LDNfor your cancer, MS, or Lupus. A Medical Doctor's license allows a physician to prescribe anything s/he thinks will help the patient.

To get LDN therapy, go to your doctor, ask him to prescribe 3 mg at bedtime, and that's it. It can't hurt you. And it might just make you live longer than you would have gotten without it. The price is quite affordable.

Watch the LDN Conference on YouTube

Further Reading

www.lowdosenaltrexone.org

www.digitalnaturopath.com/treat/T74481.html

www.ldners.org/

www.friendswithms.com/low_dose_naltrexone.htm

www.nationalmssociety.org/Clinup-Naltrexone.asp

[Shobha]

Vickie,

Thank you for being our pioneer and checking out this drug! I am praying very hard that this heals all of your mets and you are back to NED! Please keep us informed!

love,
shobha

[Laurel]

Vickie,

It has been over a month on the naltrexone. How are you doing? Any updates?

[vickie h]

Hi Laurel,
The skin mets have not changed much at all so I don't know if it is working yet. My Onc told me that it could take another month or so...and the possibility exists that it may not work. I do know that my right breast hurts a lot less and that one met under my left breast has diminished a bit, though I don't know if that is from the chemo or the Naltrexone.
I'll keep you posted if I see any big changes (cross my fingers). Hope you are well and having a great week-end.
Much love, Vickie

[jones7676]

Very interesting and thanks for sharing all the information and all your hard work!

[Believe51]

Hello Darling. I had researched this drug for The Mighty Oak for this next chemo regime. Cannot quite think of where I got the information. Sounds pretty interesting and a nice option for many in those shoes.

I am hoping that this is the magic potion for you to beat the living daylights out of those skin mets. You are on my daily prayer list and always on my mind.

I have a list of chemo meds that I will address with OncoMan on the 24th. This is surely on that list. I am trying to think of the brain and the prostate for him.

Lots of Love>>Believe51