Human / Clinical Studies
A search of the PDQ clinical trials database indicates that no clinical trials of hydrazine sulfate as a therapy for cancer are being conducted at this time.
Studies of Hydrazine Sulfate in Which Therapeutic Benefit Was Assesseda
No. = number.
a See text for more details.
b Number of patients treated plus number of control patients may not equal number of patients enrolled; number of patients enrolled = number of patients initially recruited/considered by the researchers who conducted a study; number of patients treated = number of enrolled patients who were given the treatment being studied AND for whom results were reported; historical control subjects are not included in number of patients enrolled.
c The strongest evidence reported that the treatment under study has anticancer activity or otherwise improves the well-being of cancer patients. See text and glossary for definition of terms.
d Surgery, chemotherapy, or radiation therapy given/allowed at the same time as hydrazine sulfate treatment.
e For information about levels of evidence analysis and an explanation of the level of evidence scores, see Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.
f This study included six additional patients with benign brain tumors.
g Insufficient information given to permit a level of evidence analysis.
|Reference Citation(s)||Type of Study||Type of Cancer ||No. of Patients: Enrolled; Treated; Controlb||Strongest Benefit Reportedc||Concurrent Therapyd||Level of Evidence Scoree|
|||Randomized clinical trial ||Advanced nonsmall cell lung||65; 32; 33, placebo||None||Yes||1iA|
|||Nonconsecutive case series||Various advanced ||25; 25; None||Slight regression of some metastatic lesions, 1 patient with melanoma||No ||3iiiDiii|
|||Nonconsecutive case series||Various advanced||158; 84; None||Measurable tumor regression, 7 patients||Yes||3iiiDiii|
|[4,15]||Randomized clinical trial ||Advanced nonsmall cell lung||291; 135; 131, placebo||None ||Yes||1iA|
|||Randomized clinical trial||Advanced colorectal||128; 63; 64, placebo||None ||No||1iA|
|||Randomized clinical trial ||Advanced nonsmall cell lung||243; 119; 118, placebo||None ||Yes||1iA |
|[7,9,10]||Nonconsecutive case series||Various advanced||763; 740; None ||Complete tumor regression, 6 patients||No||3iiiDiii |
|||Nonconsecutive case series ||Various advanced ||25; 25; None||None ||No||3iiiDiii|
|||Nonconsecutive case series||Various advanced ||32; 29; None ||None ||Unknown||3iiiDiii|
|||Nonconsecutive case series||Various advanced||101; 71; 30, placebo||Improved weight maintenance or gain, 41 hydrazine sulfate treated vs. 17 placebo-treated patients ||Yes||3iiiDiii|
|||Nonconsecutive case series||Glioblastoma, astrocytoma, or meningiomaf||465; 46; None||Improved survival, patients with glioblastoma ||Yes||Noneg|
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- Spremulli E, Wampler GL, Regelson W: Clinical study of hydrazine sulfate in advanced cancer patients. Cancer Chemother Pharmacol 3 (2): 121-4, 1979.
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- Loprinzi CL, Kuross SA, O'Fallon JR, et al.: Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer. J Clin Oncol 12 (6): 1121-5, 1994.
- Loprinzi CL, Goldberg RM, Su JQ, et al.: Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer. J Clin Oncol 12 (6): 1126-9, 1994.
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- Gershanovich ML, Danova LA, Kondratyev VB, et al.: Clinical data on the antitumor activity of hydrazine sulfate. Cancer Treat Rep 60 (7): 933-5, 1976.
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- Chlebowski RT, Bulcavage L, Grosvenor M, et al.: Hydrazine sulfate in cancer patients with weight loss. A placebo-controlled clinical experience. Cancer 59 (3): 406-10, 1987.
- Chlebowski RT, Heber D, Richardson B, et al.: Influence of hydrazine sulfate on abnormal carbohydrate metabolism in cancer patients with weight loss. Cancer Res 44 (2): 857-61, 1984.
- Gold J: Anabolic profiles in late-stage cancer patients responsive to hydrazine sulfate. Nutr Cancer 3 (1): 13-9, 1981.
- Herndon JE 2nd, Fleishman S, Kosty MP, et al.: A longitudinal study of quality of life in advanced non-small cell lung cancer: Cancer and Leukemia Group B (CALGB) 8931. Control Clin Trials 18 (4): 286-300, 1997.
- Tayek JA, Sutter L, Manglik S, et al.: Altered metabolism and mortality in patients with colon cancer receiving chemotherapy. Am J Med Sci 310 (2): 48-55, 1995.
- Tayek JA, Heber D, Chlebowski RT: Effect of hydrazine sulphate on whole-body protein breakdown measured by 14C-lysine metabolism in lung cancer patients. Lancet 2 (8553): 241-4, 1987.
- Filov VA, Gershanovich ML, Ivin BA, et al.: [Therapy of primary brain tumors with segidrin] Vopr Onkol 40 (7-12): 332-6, 1994.