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CancerGuide: Alternative and Complementary Therapies

Evaluating Alternative Therapies
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Promising Therapies
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Antineoplaston References
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MedLine Search: Antineoplastons

Legacy MedLine Search

This MedLine Search of the technical medical literature is from the early days of CancerGuide so it may not include the latest research. The articles referenced are still relevant but more recent ones may also be available. For more information on the incredibly powerful and freely available MedLine database see my Article on Medline.

In all cases I have selected the references that looked most interesting to me. These are searches with a point of view! There could be references on this same subject that I didn't include that you would have. For both of these reasons as well as the age of the search, you may want to consider doing your own search on this subject after looking at mine.

Finally, keep in mind that the abstracts presented here are only summaries of the actual articles. If you want to delve deeper you may want to get some of these articles from a Medical Library or an online document delivery service, as is provided with all MedLine accesses (usually for a fairly substantial fee).


Burzynski SR  Stolzmann Z  Szopa B  Stolzmann E  Kaltenberg OP
Antineoplaston A in cancer therapy. (I).

In: Physiol Chem Phys (1977) 9(6):485-500

Twenty-one patients with advanced cancer or leukemia were treated
  with antineoplaston A and followed for up to nine months. Dosage by
  intravenous, intramuscular, subcutaneous, rectal, intrapleural,
  intravesical and/or topical administration ranged from 0.6 to 33
  U/m2/24 h. Treatment was well tolerated, although side effects
  included fever of short duration and elevation of platelet and white
  blood count. In 18 cases some degree of clinical improvement was
  observed. Complete remission occurred in 4 cases. More than 50%
  remission occurred in 4 other cases which, along with another 6
  cases, are continuing the treatment with high doses of antineoplaston
  A and show a continuing regression of the tumors although not yet
  achieving the criteria for complete remission; 2 of these 6 cases
  seem unlikely to achieve remission. Two patients temporarily
  discontinued treatment. During treatment, 5 patients expired; in 2 of
  them, however, was seen significant regression of the neoplastic
  process. The deaths were not due to cancer or to any toxicity
  incurred by the treatment.

Burzynski SR  Stolzmann Z  Szopa B  Stolzmann E  Kaltenberg OP
ANTINEOPLASTON A IN CANCER THERAPY (I)
In: Physiol Chem Phys (1977) 9(6):485-500

Antineoplaston A (ANA), a peptide from human urine, was given to 21
  patients with far-advanced tumors who were followed for 1-9 mo. Most
  were resistant to chemotherapy and/or radiotherapy. ANA caused
  complete remissions (CR) in 2/2 patients with Grade III transitional
  cell carcinomas of the bladder, 1/6 with advanced breast cancer, and
  a child with acute lymphoblastic leukemia. ANA caused partial
  remissions (PR) in 2/3 patients with chronic lymphocytic leukemia
  (CLL), 1/2 with rectal adenocarcinoma, and a 20-yr-old man with lung
  metastases from synovial sarcoma. Six patients (1 each with breast
  cancer, rectal adenocarcinoma, undifferentiated ovarian tumor,
  squamous cell carcinoma of the tongue or cervix, and Ewing's sarcoma)
  showed stabilization of disease (SD). The patients with tongue cancer
  and Ewing's sarcoma relapsed within about 2 mo. All of the PR
  patients and 4/6 SD patients were continuing to improve at the time
  of report. It was hoped that the SD patients would reach a PR and the
  PR patients a CR. Five patients died during treatment, but not of
  cancer or toxicity; 2/5 showed significant tumor regression at
  autopsy. ANA caused marked central necrosis of solid tumors. Most
  patients showed a transient increase of WBC and platelet counts after
  about 1 mo of treatment. Some had a febrile syndrome, apparently
  caused by tumor cell breakdown. The recommended treatment is
  continuous iv infusion (1.2 units/m**2/day, gradually increased to 33
  units/m**2 or the development of fever) for about 1 mo, followed by
  lower doses (0.6 units, 2x/wk) im or rectally. ANA caused no
  significant toxicity at the doses used (0.6-33 units/m**2/day, iv,
  im, rectally, intrapleurally, intravesically, or topically). (14
  Refs)

American Cancer Society
UNPROVEN METHODS OF CANCER MANAGEMENT: ANTINEOPLASTONS

In: CA Cancer J Clin (1983) 33(1):57-59

Use of antineoplastons as an alleged anticancer treatment is
  discussed. Antineoplastons are described as two specific chemical
  fractions extracted and purified from human urinary peptides and
  acclaimed to inhibit growth of cancer cells in tissue culture. Only
  one study details its clinical use in 21 patients; the drug has not
  been approved by the Food and Drug Administration and no evidence has
  been submitted that it is a safe and effective method for cancer
  therapy. (10 Refs)

Burzynski SR  Kubove E  Burzynski B
Treatment of hormonally refractory cancer of the prostate with
  antineoplaston AS2-1.

In: Drugs Exp Clin Res (1990) 16(7):361-9

Successful treatment of advanced cancer of the prostate which no
  longer responds to hormonal manipulation continues to be a difficult
  task. The present study describes the results of treatment of the
  first fourteen patients in Phase II clinical trials with
  Antineoplaston AS2-1 (AS) and low-dose diethylstilbestrol (DES). The
  study involved thirteen patients diagnosed with stage IV and one
  patient with stage II adenocarcinoma of the prostate. The ages of the
  patients were between 54 and 88. The previous therapy included
  prostatectomy, orchiectomy, radiation therapy and treatment with DES,
  LHRH agonist (LH), flutamide (FL), aminoglutethimide and
  immunotherapy. After initial response to such treatments, the disease
  continued to progress. The majority of patients showed progression of
  the disease after treatment with LH and FL. The current treatment
  program consisted of administration of AS and DES. The treatment was
  given orally daily. The majority of patients received from 97 to 130
  mg/kg/24 h of AS and from 0.01 to 0.02 mg/kg/24 h of DES. The
  treatment was administered from 64 to 425 days and was free from
  significant side effects due to AS. The dose of DES was lower than
  usual, and only some patients experienced mild side effects typical
  for DES. Only two patients showed progression of the disease.
  Complete remission was obtained in two patients and partial remission
  in three patients. Stabilization of the disease with objective
  improvement was determined in seven patients. The first patient
  enrolled in the program has been in complete remission for 17 months
  and off the treatment for 16 months.(ABSTRACT TRUNCATED AT 250 WORDS)


Burzynski SR  Kubove E  Burzynski B
Phase I clinical studies of antineoplaston A5 injections.

In: Drugs Exp Clin Res (1987) 13 Suppl 1:37-43

Antineoplaston A5 is a mixture of small peptides and amino acid
  derivatives isolated from human urine which show a unique pattern of
  growth inhibition in the tissue culture of human neoplastic cells and
  no significant animal toxicity. Clinical trials described in this
  paper involved 15 patients diagnosed with advanced neoplastic
  diseases. The patients' diagnoses included: lung cancer, stage III (4
  cases); breast, stages III and IV (3); colorectal, stage IV (2);
  bladder (2); and single cases of adenocarcinoma of the jejunum, stage
  IV; adenocarcinoma of the prostate, stage IV; adenocarcinoma of the
  ovary, stage IV and astrocytoma, grade IV. Antineoplaston A5 was
  administered daily in divided doses intravenously through a
  subclavian vein catheter. The formulation was given from 47 to 130
  days. The highest dosage attained was 153 mg/kg/24 h. Adverse effects
  included febrile reaction in five patients, arthralgia in one patient
  and premature beats and pressure in the chest in one patient. The
  side-effects were very mild and usually experienced only once during
  the entire course of treatment. Desirable side-effects included
  increase of platelet count, increase of white blood cell count and
  hypertrophy of epidermis. Nine patients (60%) had objective response
  to the treatment. They were diagnosed with cancer of the lung (3
  patients), breast (2), colorectal (2) and bladder (2). Four patients
  had increasing disease and two patients were classified as having
  stable disease without objective improvement.

Burzynski SR  Kubove E
Phase I clinical studies of antineoplaston A3 injections.
In: Drugs Exp Clin Res (1987) 13 Suppl 1:17-29

Antineoplaston A3 is an oxidated mixture of small peptides and amino
  acid derivatives isolated from human urine which have shown
  antineoplastic activity in tissue culture and low toxicity in mice.
  Twenty-four patients diagnosed with 25 cases of neoplastic diseases
  were involved in the studies. The patients' diagnoses included:
  adenocarcinoma of the prostate, stage IV (7 cases); adenocarcinoma of
  the breast, stage IV (3); adenocarcinoma of the colon and rectum,
  stage IV (3); adenocarcinoma of the colon, status post resection (1);
  adenocarcinoma of the lung, stage III (2); squamous cell carcinoma of
  the lung, stage III (2); adenocarcinoma of the pancreas, stages II
  and IV (2); and single cases of adenocarcinoma of the kidney, stage
  IV; malignant fibrohistiocytoma, stage IV; glioblastoma multiforme,
  stage IV; basal cell epithelioma; and transitional cell carcinoma of
  the bladder, grade II. Only patients who had over six weeks'
  anticipated survival and who continued the treatment for over six
  weeks were eligible. In 23 patients, Antineoplaston A3 was
  administered in divided doses daily i.v. through a subclavian vein
  catheter. In one patient, the injections were given i.m. The length
  of treatment was from 44 to 478 days and the highest dosage was 76
  mg/kg/24 h. Side-effects associated with treatment included febrile
  reaction (4 patients), vertigo (2), headache (2), flushing of the
  face, nausea and tachycardia (1 each). Adverse reactions were mild
  and occurred only once during the entire course of treatment.
  Desirable side-effects included increase of platelet count, increase
  of white blood cell count and increase of reticulocyte count. At the
  end of the study, there were 5 cases of complete remission, 5 of
  partial remission, nine of stable disease and six of increasing
  disease. The patients who obtained complete remission were diagnosed
  with cancers of the bladder, prostate, colon, and basal cell
  epithelioma. In view of its very limited toxicity and the interesting
  responses obtained, Antineoplaston A3 was submitted for Phase II
  clinical trials to establish its usefulness in cancer treatment.


Burzynski SR  Kubove E

Initial clinical study with antineoplaston A2 injections in cancer
  patients with five years' follow-up.

In: Drugs Exp Clin Res (1987) 13 Suppl 1:1-11


This paper describes Phase I clinical studies of Antineoplaston A2
  injections. The studies involved 15 patients diagnosed with advanced
  neoplastic diseases including cancers of the breast, bladder, lung,
  kidney, oesophagus, colon and liver, mesothelioma and glioma.
  Antineoplaston A2 was administered in divided doses daily
  intravenously through a subclavian vein catheter. The treatment was
  given from 53 to 358 days. The highest dosage administered was 147
  mg/kg/24 h. Only minimal adverse effects were noticed sometime during
  the treatment, including fever, chills and myalgia. Desirable side-
  effects included increase of platelet and white blood cell counts,
  hypertrophy of epidermis and decrease of cholesterol and triglyceride
  levels. Nine patients showed objective response to the treatment.
  Cases of complete remission included adenocarcinoma of the lung,
  mesothelioma, metastatic liver and bladder cancers. In an additional
  case of breast cancer, the patient obtained complete remission of
  liver metastasis and stabilization of bone metastases. Partial
  remission was accomplished in cancers of the breast and oesophagus.
  Three patients, including cases of adenocarcinoma of the lung,
  mesothelioma and bladder cancer, were in complete remission for over
  five years.


Burzynski SR  Kubove E
Toxicology studies on antineoplaston A10 injections in cancer
  patients.

In: Drugs Exp Clin Res (1986) 12 Suppl 1:47-55

Antineoplaston A10 injections were administered to 18 patients
  diagnosed with 19 types of neoplastic disease. The patients'
  diagnoses included: adenocarcinoma of the rectum and colon, Stage IV
  (8 cases); adenocarcinoma of the pancreas (4 cases); adenocarcinoma
  of the breast, Stage IV (3 cases) and single cases of adenocarcinoma
  of the lungs, Stage III; adenocarcinoma of the stomach, Stage IV;
  chondrosarcoma of the nose and right maxillary sinus; and carcinoid.
  The treatment was administered from 52 to 640 days. The highest
  dosage taken was 2210.5 mg/kg/24 h. Most of the patients were taking
  from 206.9 to 387.1 mg/kg/24 h. The treatment was associated with
  minimal side-effects including febrile reactions, muscle and joint
  pain, muscle contraction in the throat, abdominal pain of short
  duration and single incidences of nausea, dizziness and headache.
  Desirable side-effects included increase of platelet count and white
  blood cell count. Objective response to the treatment was noticed in
  8 patients including one patient diagnosed with intraductal carcinoma
  of the breast, Stage IV, 2 patients with adenocarcinoma of the
  sigmoid, Stage IV, 1 patient with adenocarcinoma of the rectum, Stage
  IV, 2 patients with adenocarcinoma of the pancreas, 1 patient with
  adenocarcinoma of the lung, Stage III, and 1 chondrosarcoma.


Burzynski SR  Burzynski B  Mohabbat MO
Toxicology studies on antineoplaston AS2-1 injections in cancer
  patients.

In: Drugs Exp Clin Res (1986) 12 Suppl 1:25-35

Antineoplaston AS2-1 is a mixture of two products of hydrolysis of
  Antineoplaston A10 and consists of sodium salts of
  phenylacetylglutamine and phenylacetic acid in the ratio of 1:4.
  Antineoplaston AS2-1 injections were administered to 20 patients
  diagnosed with 21 types of neoplastic diseases. The patients'
  diagnoses included: lung cancer, stage III, 4 cases; colorectal,
  stage IV, 3; breast, stage IV, 2; breast in remission, 1;
  glioblastoma, 3; head and neck, stage IV, 3; uterine cervix, stage
  IA, 1; chronic myelocytic leukaemia, 2; lymphocytic lymphoma, stage
  IV, 1; and leiomyosarcoma of the uterus, stage IVB, 1. Antineoplaston
  AS2-1 was administered every 6 h i.v. through subclavian vein
  catheter. The treatment was administered from 38 to 872 days. The
  highest dosage taken was 160 mg/kg/24 h. The treatment was associated
  with minimal side-effects, including slight nausea and vomiting in
  one patient, mild allergic reaction in the form of maculopapular rash
  in another patient and moderate elevation of blood pressure in an
  additional patient. One patient developed febrile reaction and three
  patients had mild electrolyte imbalance. Only one patient showed
  slight decrease of WBC. Desirable side-effects included improved
  healing of chronic atrophic ulceration. The response to the treatment
  included 6 complete remissions, 2 partial remissions, 7 cases of
  stabilization and 6 cases of increasing disease. Three patients are
  alive, well and free from cancer 5 years after the beginning of the
  study. The hypothetical mechanism of action of Antineoplaston AS2-1
  as an anticancer agent is described.


Burzynski SR
Toxicology studies on antineoplaston AS2-5 injections in cancer
  patients.

In: Drugs Exp Clin Res (1986) 12 Suppl 1:17-24

Antineoplaston AS2-5 is one of the degradation products of
  Antineoplaston A10. The chemical structure of Antineoplaston AS2-5
  corresponds to phenylacetylglutamine. Toxicology studies of
  Antineoplaston AS2-5 injections involved 13 patients diagnosed with
  15 types of neoplastic disease, including: lung cancer, 3 cases;
  breast, 3 cases; colon, 2 cases; and single cases of cancer of the
  larynx, prostate, stomach, pancreas, malignant fibrohistiocytoma,
  embryonal teratoma and lymphocytic lymphoma. Antineoplaston AS2-5 was
  injected i.v. daily through subclavian vein catheter in divided
  doses. The treatment was administered from 41 to 436 days. The
  highest dosage given was 167.6 mg/kg/24 h. The treatment was
  associated with only very mild side-effects, including febrile
  reaction in two patients and swelling of small joints in one patient.
  Two patients had beneficial side-effects, including increase of
  platelet count and increase of concentration of plasma globulin. The
  treatment resulted in two complete remissions, one mixed response,
  four cases of stabilization and six cases of increasing disease.
  Complete remission was achieved in squamous cell carcinoma of the
  larynx, stage II, and large cell undifferentiated carcinoma of the
  lung with lymph nodes and liver metastases. One patient had mixed
  response during the treatment of carcinoma of the breast with
  metastases to the lymph nodes, liver and skin and obtained complete
  remission of liver metastases but increasing disease of skin
  metastases. Eight patients discontinued the treatment and three
  patients died during the trials. The patient diagnosed with lung
  cancer who obtained complete remission continues to be free from the
  disease over 5 years after the beginning of the treatment.(ABSTRACT
  TRUNCATED AT 250 WORDS)

Burzynski SR  Mohabbat MO  Burzynski B
TOXICOLOGY STUDIES ON ORAL FORMULATION OF ANTINEOPLASTON A10 IN
  CANCER PATIENTS


In: Future Trends Chemother (1985) 6:485-93

Antineoplaston A10 (AN A10; 3-phenylacetylamino-2,6-piperidinedione)--
  the first compound belonging to the group of antineoplastons to be
  identified and reproduced by synthesis--tested in animals did not
  show any significant toxic effects and has LD50 equal to 10.33 g/kg.
  Chronic administration of AN A10, 500-mg capsules, is described for
  42 patients diagnosed with 49 types of advanced neoplastic disease:
  breast cancer (13 cases); prostate (7); lung (7); colorectal (4);
  kidney (2); bladder (2); single cases of cancer of the stomach,
  pancreas, cervix, ovary, and parotid gland; 3 cases of primary
  malignant brain tumor; 5 leukemias and lymphocytic lymphomas, and 1
  unknown tissue diagnosis. The shortest duration of treatment was 6
  days and the longest 314 days; most of the patients were treated for
  50-149 days. The highest dose of AN A10 per 24 hr was 14.0 g; the
  highest dosage of AN A10 taken was 288.4 mg/kg/24 hr. Results are
  presented for (1) adverse reactions (cardiovascular, febrile
  reaction, gastrointestinal symptoms, hypersensitivity, hypoglycemia,
  hypokalemia, myelosuppression, neurological effects) and (2) cancer
  treatment (complete or partial remission, stable disease, increasing
  disease, withdrawal from treatment, additional beneficial effects
  from treatment). Treatment was associated with minimal adverse
  reactions which included excess gas in the stomach, gastrointestinal
  bleeding (probably not related to AN A10), maculopapular rash,
  moderately increased blood pressure, vertigo, hypoglycemia,
  hypokalemia, and mild myelosuppression. Evaluation of anticancer
  activity was not the main purpose of the study; however, at least
  some positive response reflected by clinical improvement was found in
  75% of the 49 cases studied. In the majority of cases (51%), the
  positive response was limited to stabilization. Additional beneficial
  effects of treatment with AN A10 included decrease of plasma levels
  of triglycerides and cholesterol, increase in white blood count, red
  blood count and platelet count, and the improvement of blood
  clotting. (8 Refs)


Burzynski SR  Kubove E  Szymkowski B  Burzynski B
Phase II clinical trials of novel differentiation inducer--
  antineoplaston AS2-1 in AIDS and asymptomatic HIV infection.

In: Int Conf AIDS (1992 Jul 19-24) 8(3):61 (abstract no. PuB 7074)

OBJECTIVES: Demonstration of objective improvement in AIDS and
  asymptomatic HIV infection (AHIV) in response to treatment with
  Antineoplaston AS2-1 (AS). METHODS: Seventy evaluable patients
  included in the studies were divided into 3 groups: AHIV, AIDS not
  previously treated, and AIDS resistant to antiviral therapy (AIDSR).
  AHIV patients were given the average oral dosage of 50mg/kg/24h, and
  AIDS and AIDSR 35mg/kg/24h. The responses were evaluated using
  generally accepted criteria with special emphasis on CD4+ counts. The
  patients in the AHIV group had pretreatment CD4+ counts below
  500/mm3, and the majority in the AIDSR group had CD4+ counts from 0
  to 40/mm3. The duration of the studies was 180 days. RESULTS: The
  evaluation after 60 to 90 days revealed response rates of 68% for
  AHIV, 81% for AIDS and 61% for AIDSR. After 180 days of treatment,
  the response rates decreased to 64% for AHIV, 44% for AIDS and 28%
  for AIDSR. A number of patients discontinued the treatment during the
  first 6 months for nonmedical reasons. At the time of this report
  only a small number of patients, who decided to continue therapy over
  180 days, completed 10 to 12 months of treatment. The majority of
  these patients continue to show objective improvement. There were no
  significant side effects associated with the treatment. Responding
  patients had marked increase of CD4+ count. The highest net increase
  of CD4+ counts were 450/mm3 (AIDSR), 430/mm3 (AHIV), and 220/mm3
  (AIDS). There was marked clinical improvement, including increases of
  energy and weight, and a decrease of opportunistic infections.
  CONCLUSION: It is concluded that (AS) shows therapeutic activity in
  the treatment of AHIV, AIDS and AIDSR. Additional study will be
  required to determine the response rate in a large number of
  patients.


Tsuda H
Inhibitory effect of antineoplaston A-10 on breast cancer
  transplanted to athymic mice and human hepatocellular carcinoma cell
  lines. The members of Antineoplaston Study Group.

In: Kurume Med J (1990) 37(2):97-104


The inhibitory effect of Antineoplaston A-10 was tested on the growth
  curve of human breast cancer (R-27) serially transplanted to athymic
  mice and on the cell growth of human hepatocellular carcinomas (KMCH-
  1, KYN-1, KIM-1). Approximately 1.25% of Antineoplaston A-10 in the
  regular mouse diet (CE2) inhibited the growth curve significantly
  after 35 days treatment (p less than 0.05). Seventy milligrams of
  daily intraperitoneal administration of Antineoplaston A-10 Injection
  also inhibited the growth curve of R-27 after 52 days treatment (p
  less than 0.01). Histological study of tumor showed no essential
  difference in structure but significant decrease in number of mitoses
  in the Antineoplaston A-10 treated groups. The cell growth of human
  hepatocellular carcinoma cell lines KMCH-1, KYN-1 and KIM-1 was
  inhibited by Antineoplaston A-10 Injection dose dependently.

Institutional address:
     Kurume University School of Medicine
     Japan.


Hashimoto K  Koga T  Shintomi Y  Tanaka M  Kakegawa T  Tsuda H  Hara H
The anticancer effect of antineoplaston A-10 on human breast cancer
  serially transplanted to athymic mice.

In: Nippon Gan Chiryo Gakkai Shi (1990 Jan 20) 25(1):1-5

We report the effects of Antineoplaston A-10 Injection on the growth
  curve of human breast cancer (R-27) serially transplanted to athymic
  mice. The intraperitoneal administration of 1/4 LD-50 (50 mg/mouse)
  of Antineoplaston A-10 Injection every day and 1/2 LD-50 (100
  mg/mouse) every other day for 35 days was found to significantly
  inhibit the growth curve and also the 3H-TdR uptake was inhibited by
  73.7% in those given 1/4 LD-50 and by 77.1% in those given 1/2 LD-50.
  The tumor histology in both groups showed necrosis but no lymphocyte
  infiltration.




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