Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00003509|
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Results First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Current therapies for Stage IV Melanoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Melanoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Melanoma||Drug: Antineoplaston therapy (Atengenal + Astugenal)||Phase 2|
Stage IV Melanoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.
- To determine the efficacy of Antineoplaston therapy in patients with Stage IV Melanoma, as measured by an objective response to therapy (complete response, partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Melanoma.
- To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma|
|Actual Study Start Date :||March 27, 1996|
|Actual Primary Completion Date :||February 14, 2005|
|Actual Study Completion Date :||February 14, 2005|
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Patients with Stage IV Melanoma will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other Name: A10 (Atengenal); AS2-1 (Astugenal)
- Number of Participants With Objective Response [ Time Frame: 5 months ]Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003509
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Principal Investigator:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|