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Potential Therapies for HRPC - Evaluations of Drugs
and Treatments That are not yet FDA-approved for HRPC. Also Provides
Information on clinical trials.
TABLE OF CONTENTS
Introduction
Clinical Trial Resources
Compassionate Use for Access to Unapproved Drugs. This link will take you to
an article that 1st appeared in the Fall 2004 issue of Cure Today. It describes
the FDA's Early Access Program and single patient use. You need to know
the criteria, understand the law, do a lot of leg work and enroll your doctor in
this quest. Another resource for compassionate use is located on the .American
Cancer Society Compassionate Use webpage; The US National Cancer Institute
also covers this topic - "Access
to Investigation Drugs - Questions and Answers." Lastly, the US FDA
has, "Access to Unapproved
Drugs." It is not an easy process.
Some specific drugs of interest to HRPC patients:
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Abiraterone
acetate (CB7630). There are now multiple clinical trials in progress for
abiraterone.
Abiraterone trials world wide and
US.
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Alpharadin (this is a link to the
manufacturer's website) - a new radiopharmaceutical Radium 223 and emits alpha
particles (helium nuclei) as opposed to the beta particle emitters like
samarium or strontium. Currently in phase II testing. Alpharadin is
being developed for skeletal metastases in patients with late-stage, HRPC.
Algeta is expecting to progress Alpharadin to pivotal Phase III clinical
studies in 2008 based on positive Phase II data, which show that it delays the
progress of prostate cancer and reduces the extent and effect of metastasis.
-
Atrasentan
(ABT – 627) Phase III clinical trials are running to evaluate this
drug that may delay progression of bone metastases and reduce pain. The new name
is Xinlay™.
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COX-2 Inhibitors(and
NSAIDS). Off-label use.
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Sulindac (clinoril)
This is a possible interim approach while the drug Aptosyn finishes clinical
trials and gets FDA approval. Off-label use.
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Exisulind(Aptosyn).
Development of this drug has likely been discontinued.
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Ixabepilone.
This
is a Bristol-Myers-Squibb chemotherapy drug under development whose orignal
designation was, BMS-247550. It is a semi-synthetic analog of Epothilone B. The
epothilones are a class of non-taxane microtubule-stabilizing agents. Bill Aishman
wrote a paper in 2003 about this drug's development - before the results of
various HRPC clinical trials were published, see "Epothilone B, A New, Effective
Chemotherapy Drug for Advanced Prostate Cancer in Our Lifetime?"
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MoAbs -
A Personal Experience With a Targeted
Chemotherapy Clinical Trial
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Noscapine - This is an over-the-counter
cough suppressant that has show in vivo that it is an
anti-PCa agent.
The PCREF organization is working to bring this into testing with patients (see
the Noscapine website). 7 March 2007.
-
Phenoxodiol, a synthetic anticancer drug analog
of genestein currently being tested for ovarian cancer. There has been one
trial in HRPC patients that showed lots of promise.
-
Quadramet
(Samarium) with a Vaccine. The official title of this phase 2.5 clinical trial
is: "A
Randomized Phase 2.5 Study of 153Sm-EDTMP (Quadramet) With or Without a
PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer
NCI-07-C-0106." The rationale for this combination is
that the PROSTVAC-V/TRICOM vaccine has been shown to be safe and to have some
preliminary activity plus there have been pre-clinical studies suggesting that
there is synergy between Quadramet and immunotherapy (see abstract #4398, 97th
AACR Annual Meeting, April 1-5, 2006.). Prior taxotere use allowed. Bone
metastases required, but no soft tissue disease.
Arm I:
Patients receive 153Sm-EDTMP IV over one minute on Day 8
Treatment with 153Sm-EDTMP will be repeated every 12 weeks if there is
adequate hematologic recovery
Arm II:
Patients receive PROSTAC-V/TRICOM (vaccine) subcutaneously on Day 1
Patients receive 153Sm-EDTMP IV over one minute on Day 8
Treatment with 153Sm-EDTMP will be repeated every 12 weeks if there is
adequate hematologic recovery
Patients receive PROSTVAC-F/TRICOM (fowlpox) subcutaneously on Days 15, 29,
and then every 4 weeks
Patients receive sargramostim (GM-CSF) subcutaneously daily for 4 consecutive
days, beginning the day of each PROSTVAC vaccination
-
Satraplatin(JM-216).
Withdrawn, failed phase III Sparc - median survival no better than prednisone
alone. Satraplatin is being developed as a second-line chemotherapy for HRPC
patients. See the news release from 23 February 2007, entitled, "Satraplatin
Shown to Significantly Reduce Risk of Disease Progression in Advanced
Hormone-Refractory Prostate Cancer Patients."
-
Vaccines, includes a personal account of the Provenge vaccine trial.
-
Valproic Acid (Depakote ER). This drug is
available "off label" for HRPC. Its use for HRPC isn't proven yet.
-
Velcade. Velcade
was also known as PS-341, MLN341 and LDP-341. It's generic designation is "Bortezomib"
and it is a proteasome inhibitor. This paper, by Bill Aishman, is entitled, "Velcade:
the Magic Bullet for Cancer?"
For a list of "emerging therapies"
and some information about them, visit the Us Too website page at
http://www.ustoo.org/Emerging_Treatments.asp
In this section we present our evaluations of various new and old therapies that may have some effect on
HRPC. Keep in mind that we are not doctors—just patients who do our homework. We are trying to provide rational options that you can review with your oncologist.
We identify some of these therapies through our internet contacts and some through media announcements. It is our belief that there are also some answers out there in the medical literature that—for whatever reason—are not being pushed by the medical community or the pharmaceuticals. By sorting out these therapies we hope to help our medical teams by providing workable ideas for consideration.
Since there is some urgency to our search, we have established criteria that are meaningful to us as people living with
HRPC:
Is there hard evidence that this therapy has beneficial effects for humans with
HRPC? We consider evidence to be published clinical studies in the recognized medical literature. Or it may be documented anecdotal evidence by people with no financial stake in the product. Pre-clinical studies (in vitro and in vivo with mice) rarely translate to successful drugs and even more rarely in fewer than 10 years.
Is there hard evidence that this drug will not harm or kill the user? Simply put, if this one doesn’t work, will I survive to continue my fight?
-
Is this drug available now (or within 12 months) for use? Tough question. But, if you can’t get it, it’s of no value in your fight against
HRPC. However, it may be available in a trial or under compassionate use, so don’t write off a good prospect without trying.
Using these criteria, we have tried to provide a meaningful evaluation of new therapies so that you have the basis for a discussion of potential therapies with your oncologist. Each evaluation is reported in a similar format to help you compare alternatives.
None of us has any stake, financial or otherwise, in any of these therapies. We are all simply looking for the best answers available today for
HRPC.
If you learn something of value as a result of using these evaluations, we will appreciate hearing from you so that we can continue to build this database of knowledge for everyone’s use.
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