Phase 2 Mesothelioma Trial, Terminated NCT00003508 Sponsor: Burzynski Research Institute Condition: Mesothelioma
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT00003508) looked at a treatment called Antineoplaston Therapy. Eight people took part in the study, though only three completed it, and five did not complete it. The trial was measuring how participants' disease responded to the treatment, using standard criteria that categorise responses as a complete response (disease disappearing entirely), a partial response (disease shrinking by at least half), stable disease (disease not changing much), or progressive disease (disease getting worse). The reported data shows that out of the eight participants, zero had a complete response, two had a partial response (meaning their measurable disease shrank by 50% or more for at least four weeks), one had stable disease (meaning their disease did not change significantly for at least twelve weeks), and five were listed as "not evaluable" — meaning their results could not be assessed using the trial's criteria. No figures for progressive disease were separately reported in the data provided. It is worth noting that this was a very small study with only eight participants, and five of those could not be assessed, so the reported data covers a limited number of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Mesothelioma Trial, Terminated

NCT00003508
Terminated Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with stage IV mesothelioma (confirmed by a tissue sample/biopsy) that is unlikely to respond to current treatments and cannot be cured with existing therapies
  • Your cancer has been detected by a CT scan or MRI
  • You are aged 1 or older
  • You are reasonably active and able to carry out daily activities (as measured by a standard medical scale called Karnofsky, scoring between 60–100%)
  • You are expected to live for at least 2 months
  • Your blood cell counts are at an acceptable level (white blood cells and platelets above certain minimums)
  • Your liver is functioning well enough, with blood test results within acceptable ranges
  • Your kidneys are functioning well enough, with results within acceptable ranges
  • You have recovered from any previous surgery before joining the trial
  • At least 4 weeks have passed since any previous immunotherapy or chemotherapy (or 6 weeks for a specific type of chemotherapy called nitrosoureas), and you have recovered
  • At least 8 weeks have passed since any previous radiation therapy and you have recovered (confirm with trial site if you had multiple tumours treated)

Who may not be able to join:

  • You are pregnant or currently breastfeeding
  • You are able to have children but are unwilling to use effective contraception during the trial and for 4 weeks afterwards
  • You have a significant non-cancer-related illness affecting your whole body
  • You have an active infection of any kind
  • You have uncontrolled high blood pressure
  • You have a history of heart failure
  • You have a heart or blood vessel condition that makes receiving high doses of sodium unsafe
  • You have serious lung disease, such as chronic obstructive pulmonary disease (COPD)
  • You have a kidney condition that makes receiving high doses of sodium unsafe, or have kidney insufficiency
  • You are considered to be at high medical or psychiatric risk (confirm with trial site)
  • You have previously been treated with a type of therapy called antineoplastons
  • You are currently taking immune-modifying medications or other cancer treatments alongside this trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Burzynski Research Institute
Registry
ClinicalTrials.gov
Start date
8 March 1996
Est. completion
26 April 2005

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov