Cyclophosphamide availability

[neweimear]

Hi all
Seeing as Fluge & Mella are trialling cyclophosphamide and there seems to be some responders at least, hopefully results will be published shortly of current trial. Is it likely that cyclo will be made available perhaps in Private Clinics in Norway in the next year if results are good or is the idea to find other less toxic drugs that may be beneficial for us, cyclo is simply a stepping stone toward that, not a drug that will be made available to us. Any thoughts? Sweet God, will we ever see treatment!!!

 

[Kati]

Hi @neweimear Cyclo is available worldwide and is fairly cheap. However as you mentioned it is a cytotoxic drug that should not be administered at home or without supervision of someone VERY knowledgeable in the kinds of toxicities that Cyclo presents with.

The think is, at this point we do not understand yet what the exact pathology of ME and what Cyclo does if it turns out to work in our patient population. We have not teased the subsets as of yet. There is so much work to be done.

I am hoping we can get more clarity once this trial publishes, and I am hoping that the research teams can get closer to find out cause and pathology of what ails us all, with the hope that it will attract further researchers, pharma, and very importantly serious funding to the field.

 

[neweimear]

Hi Kati, that all sounds sensible but I feel every day is a day lost....if cyclo works for 2/3 patients, I would be almost willing to take my chances. Cyclo is available worldwide but an onocologist or rheumatologist willing to administer to an ME patient is a different matter. I hope some treatment options become available in next 2 to 3 years. Risky or not,

 

[Kati]

Hi Kati, that all sounds sensible but I feel every day is a day lost....if cyclo works for 2/3 patients, I would be almost willing to take my chances. Cyclo is available worldwide but an onocologist or rheumatologist willing to administer to an ME patient is a different matter. I hope some treatment options become available in next 2 to 3 years. Risky or not,

I hope so too @neweimear. The clinical trial framework is in place so that the most important questions are asked:
- is this drug safe at the dosage evaluated? (Have any patient died?)
- is this drug effective?
- are there further toxicities for the patient group tested?
- what is the optimal dosage?
- which group (or subset) of paient is more likely to respond.

I am impatiently waiting for the paper to publish.

 

[neweimear]

Cant wait to hear results!!

 

[me/cfs 27931]

Cant wait to hear results!!

Here's hoping Xmas comes early this year.

 

[Jesse2233]

This is very anecdotal so take it with a grain of salt, but from what I've heard around 30-40% of the RTX non-responders from the Phase 2 trial had a clinically significant response to CTX. Also the initial side effects are quite difficult. We'll have to wait and see if the actual study confirms this.

 

[deleder2k]

From what I've heard some patients experienced nasty side effects. Deterioration of their ME symptoms. Some ME patients experience gets worse than regular patients that get cyclo for cancer. I think they are thinking about lowering the dosage to see if it yields the same results.

 

[Snow Leopard]

From what I've heard some patients experienced nasty side effects. Deterioration of their ME symptoms. Some ME patients experience gets worse than regular patients that get cyclo for cancer. I think they are thinking about lowering the dosage to see if it yields the same results.

Doesn't surprise me. Cyclophosphamide is not a friendly drug.

 

[neweimear]

I think alot of us would undergo treatment with rough side effects if we thought we would get a remission that would last for a reasonable amount if time. If results of cyclo trial are good, its finding a doctor that will prescribe it for ME that could be a problem down the line, considering alot of doctors dont recognise it for the serious illness it is. Will we all be jetting to Norway down the line. It seems to be the only country that is developing reasonable recognition for M.E.

 

[Kenny Banya]

Will we all be jetting to Norway down the line. It seems to be the only country that is developing reasonable recognition for M.E.

Not if it's listed with the European Medicines Agency

 

[deleder2k]

Not if it's listed with the European Medicines Agency

What do you mean? As long as the drug is approved the drug can be used. The laws in each country decide whether off-label use is allowed or not.

 

[Kenny Banya]

What do you mean? As long as the drug is approved the drug can be used. The laws in each country decide whether off-label use is allowed or not.

Listed, so it can be used on-label & hence paid for by governments

 

[jpcv]

@Snow Leopard, @neweimear , @Kenny Banya ,@deleder2k , @Jesse2233
My perspective , as a Clinical Oncologist and ME patient,on the use of Cyclo:

1-Cyclo is a cheap drug, much more affordable than RTX, so I imagine that more people will be able to pay for the treatment.
2-I think Cyclo , used as a single drug,in the dosage described in the trial abstract,is a friendly drug.
I have treated countless patients with this dosage and schedule, and also in association with another drugs.
Obviously there are side efects, but they are manageable, and in the rare cases that a patient has significant toxicity, it usualy comes from the drugs used with cyclo.
3- maybe ME patients have more side effects with the drug, that´s why it´s important to wait for the trial results: eficacy, side effects and so on.
4- If the trial shows that Cyclo works, with side effects usualy known to the drug, I would take it without blinking.
It doesn´t have to cure you, a performance status improvement is a valid goal.

 

[neweimear]

Thank you jpcv for that interesting info. So looking forward to trial results, as you say an improvement would be so welcome...@jpcv do u know if cyclo can put other autoimmune conditions into remission or would maintenance treatment with cyclo be needed?

 

[BurnA]

Thank you jpcv for that interesting info. So looking forward to trial results, as you say an improvement would be so welcome...@jpcv do u know if cyclo can put other autoimmune conditions into remission or would maintenance treatment with cyclo be needed?

From Jonathan Edwards on another thread

Cyclophosphamide works quickly in inflammatory autoimmune disease because it kills inflammatory cells as well as B cells. The real problem with cyclo is that the effect does not last - certainly in RA. There is clear rapid benefit from cyclo infusions almost at once but by 3 months you are back to square one. That is because cyclo does not block the recruitment of new B cells, it just kills the ones already there.

It is all a bit complicated but it makes sense. When I treated RA with rituximab and cyclo I worked on the basis that the effect of cyclo would be gone by 3 months so I assessed patients at 6 months.

 

[neweimear]

Gosh, 3 mths of an improvement would be very little given the harshness of cyclo. Maybe ME patients will respond in a different way, I understand monthly infusions were given for 6 months and patients then monitored for next 12 months...

 

[deleder2k]

Remember that ME is not R.A

@jpcv, some of the patients had more side effects than cancer patients get. I think they are doing a new pilot now with a lower dosage to see whether they can reduce side effects while maintaining the effect on the ME symptoms. I guess we will know much more about this when the study is published. Hopefully before Jesus' birthday.

 

[jpcv]

Gosh, 3 mths of an improvement would be very little given the harshness of cyclo. Maybe ME patients will respond in a different way, I understand monthly infusions were given for 6 months and patients then monitored for next 12 months...

Yes, I agree with you, . Taking cyclo once in a month for 6 months is one thing, taking it multiple times is much more toxic.

 

[Kenny Banya]

@Snow Leopard, @neweimear , @Kenny Banya ,@deleder2k , @Jesse2233
My perspective , as a Clinical Oncologist and ME patient,on the use of Cyclo:

1-Cyclo is a cheap drug, much more affordable than RTX, so I imagine that more people will be able to pay for the treatment.
2-I think Cyclo , used as a single drug,in the dosage described in the trial abstract,is a friendly drug.
I have treated countless patients with this dosage and schedule, and also in association with another drugs.
Obviously there are side efects, but they are manageable, and in the rare cases that a patient has significant toxicity, it usualy comes from the drugs used with cyclo.
3- maybe ME patients have more side effects with the drug, that´s why it´s important to wait for the trial results: eficacy, side effects and so on.
4- If the trial shows that Cyclo works, with side effects usualy known to the drug, I would take it without blinking.
It doesn´t have to cure you, a performance status improvement is a valid goal.

Thank you for contributing to the forum