Re: Need advice on clinical trials


J wrote:
PM wrote:

PM wrote:
IIRC their work was entirely in the test tube, and under very
artificial conditions at that (heavy iron loading of the cells that is
probably impractical in vivo). I am also unaware of any evidence that
Artemisin has yet shown any clinical effectiveness, i.e. effects on
cancer in humans, although I understand it is under study in some
places. Do you have any better evidence to present?

<snipped some>

This is a bit unfair. I actually checked Medline to see if there were
any recent
publications of clinical results from Artemisinin before I posted my
comments. . I even asked you politely if you had any clinical
evidence. I am trying to keep up to date on this kind of thing all
the time.

There's one case report, 6 years ago here
<http://www.onk.ns.ac.yu/archive/Vol10/PDFVol10/V10n4p279.pdf>
A seventy-two year old vegetarian male with a long history of tobacco chewing
and smoking was admitted to Vivekanand Hospital (Meerut, India) on December 15,
2000.

stage II cancer of the larynx (T2 N1 M0). A diagnosis of differentiated
squamous cell carcinoma was established after histopathological examination of
a biopsy from the growth. The patient complained of plained of progressive
hoarseness, and loss of appetite and weight for the last eight months. Physical
examination revealed enlarged cervical lymph nodes on the right side of the
neck

Laryngoscopic examination showed a growth on the right side of the larynx.. The
growth was covering the right vocal cord, right pyriform fossa, ventral aspect
of epiglottis, and adjacent area of the lateral pharyngeal wall. The surface of
the growth was irregular, nodular, ulcerated and bled on touch.
Its size was approximately 3 cm x 2.5 cm x 3 cm=22.5 cm

[He'd had intermittent pain and swallowing difficulties for the previous 6
months. - me summarizing]

artesunate treatment was started on 01/22/2001. On day one of treatment, a
capsule containing ferrous sulfate (150 mg) and folic acid (0.5 mg) was given
orally at 2:00 PM after a meal. Injections of artesunate (60 mg I.M. per day;
were given from day one (01/22/2001) to day 15 (02/05/2001) at 10:00 PM of each
day.
The patient had a fever (100-101°F) from day four to day seven of the
treatment.
Within two weeks of the treatment, his voice became clear. The patient was able
to take solid foods quite comfortably. He regained a good appetite. Clinical
examination revealed cervical lymph nodes were reduced in size.
Without treatment, laryngeal cancer patients die within an average of 12 months
(1).
The patient lived for nearly one year and eight months (until his death on
1/11/02 due to pneumonia) after the appearance of symptoms, although treatment
was discontinued after nine months.

In an unrelated note, the patients had extensive patches of leukoderma around
his mouth, on fingers of both hands, which responded well to artesunate
treatment over the nine months of observation.

Since this case, several patients with different types of cancers have begun
treatment with artemisinin and its analogs with promising results.

Narendra P. SINGH
Krishna B. VERMA
Archive of Oncology 2002;10(4):279-80.
The authors are grateful to Miss Himani Singh for her help in preparation of
the manuscript."

No idea what happened to the other patients mentioned.
I think it says the author (Singh) can be contacted.
J

J, this is not a very convincing case, being consistent with infection
in a moderately advanced laryngeal tumour where the clinical
improvement may have been due to the infection settling down (note high
fever in the early phase of the illness, which is not a usual response
to any kind fo chemotherapeutic or immunological cancer treatment).

The only impact described on the cancer itself was reduction in size
from 3cm in diameter to 2.25cm in diameter, the method of measurement
is not described, and the cancer is never shown to go away despite nine
months of the treatment. . The patient died about twenty months later
which would be within the usual range for an untreated
well-differentiated laryngeal tumour.

There are other aspects to this that make me doubtful as to the
objectivity and professionalism of the authors, such as insisting that
the patient died of pneumonia (why? that is how many laryngeal; cancer
patients die).

This is NOT how cancer research should be carried on. If these people
have access to patients in India who are prepared to forgo treatments
that may induce even better palliation and prolongation of life then
let them engage an oncologist who knows what he is doing and perform
some proper Phase l and Phase ll studies of the drug.

Peter Moran

.

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