#Burzynski - is this normal clinical trial practice?

The year before last I wrote a blog post expressing surprise at how many trials the Burzynski Clinic had running and after recent events (rumours that the Burzynski clinic is under unprecedented scrutiny from the FDA, but note this caveat tweeted by @medtek) I wondered what had changed.

Back in November 2011 I found 61 trials, this year by searching for the name Burzynski it seems there are now 62 (however the last one, this trial, actually relates to a completely different Burzynski so no change in numbers at all, h/t @dianthusmed).

It also appears that there have been more trials but not all of them registered, according to a paragraph on a page from 1998 on Quackwatch's website, highlighted to me by @jonmendel

"Working outside peer review, Burzynski is conducting 71 concurrent, preliminary phase II trials that cover most cancer indications-an unheard of number for a single investigator, and for a drug which is yet to be proven effective for any indication."

What struck me was that the ones I looked at on the first page (of 'unknown' status) all follow the same format of "Antineoplaston therapy in treating X (patients) with Y (type of cancer)" and all on the first page (shown below) are followed by this line (indicating the type of treatment given) appears below all of them: Interventions:     Drug: antineoplaston A10;   Drug: antineoplaston AS2-1

From the first page of results (brown = status unknown for more than two years, red = withdrawn, purple = terminated, green = completed - though is it published and what happened?):

• Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
• Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma
• Antineoplaston Therapy in Treating Patients With Brain Tumors
• Antineoplaston Therapy in Treating Children With Brain Tumors
• Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
• Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma 
• Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
• Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
• Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
• Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
• Antineoplaston Therapy in Treating Patients With Refractory or Recurrent Intermediate-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
• Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
• Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
• Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
• Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
• Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
• Antineoplaston Therapy in Treating Patients With Multiple Myeloma
• Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
• Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
• Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy

Are all these trials running at the same time? The way the titles are written it seems as if the antineoplastons A10 and AS2-1 are being trialled in children and adults with a fairly broad range of cancer types (or stages of a particular cancer type).

Searching for antineoplaston A10 brings up 61 hits and searching for antineoplaston AS2-1 brings up 60, so possibly there's at least one Burznyski trial listed in the 62 that has nothing to do with antineoplastons (could be someone with the same name of course).

Is that usual where the type or stage of cancer has a very poor prognosis and no-one has the luxury of time to wait and see how these ANPs perform in one situation before trying them in the next?

For comparison I had a look at GLP-1 and spotted a few that had similar titles, but there seemed to be much more variance in title, and trial status. One is even listed as having results...

Feb 2012 - Searching just for the antineoplaston A10 trials, we get 61 of which:

• 0 are recruiting
• 50 are of unknown status
• 7 are withdrawn
• 2 are terminated
• 1 is completed
• 0 are active, not recruiting
• 1 is not yet recruiting

Note that Unknown status incorporates some of the other categories

UNKNOWN (RECRUITMENT STATUS)

A clinical study in ClinicalTrials.gov with a status of Recruiting; Not yet recruiting; or Active, not recruiting and whose status has not been confirmed within the past 2 years. Studies with an Unknown recruitment status are considered open studies or closed studies, depending on their last recorded recruitment status.

Nov 2011 - Here's what I found in November 2011 (but I think I searched on Burzynski rather than antineoplaston A10 so there's a caveat there)

• 10 are recruiting
• 35 are of unknown status
• 7 are withdrawn
• 2 are terminated
• 1 is completed - it began in March 1996 and was completed in 2005. Its clinical identifier is NCT00003509 and this does not appear anywhere in PubMed.
• 5 are active, not recruiting
• 1 is not yet recruiting

While writing this post @majikthyse also published a post on the Burzynski Clinic which makes very interesting reading.

Comments relating to conspiracy theories or personal attacks on anyone will be ignored.