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Studies of Hydrazine Sulfate in Which Therapeutic Benefit Was Assesseda

Reference Citation(s) Type of Study Type of Cancer  No. of Patients: Enrolled; Treated; Controlb Strongest Benefit Reportedc Concurrent Therapyd Level of Evidence Scoree 
[1]Randomized clinical trialAdvanced nonsmall cell lung65; 32; 33, placeboNoneYes1iA
[4,15]Randomized clinical trialAdvanced nonsmall cell lung291; 135; 131, placeboNoneYes1iA
[5]Randomized clinical trialAdvanced colorectal128; 63; 64, placeboNoneNo1iA
[6]Randomized clinical trialAdvanced nonsmall cell lung243; 119; 118, placeboNoneYes1iA
[2]Nonconsecutive case series Various advanced25; 25; NoneSlight regression of some metastatic lesions, 1 patient with melanomaNo3iiiDiii
[3]Nonconsecutive case seriesVarious advanced158; 84; NoneMeasurable tumor regression, 7 patientsYes3iiiDiii
[7,9,10]Nonconsecutive case seriesVarious advanced763; 740; NoneComplete tumor regression, 6 patientsNo3iiiDiii
[8]Nonconsecutive case seriesVarious advanced25; 25; NoneNoneNo3iiiDiii
[11]Nonconsecutive case seriesVarious advanced32; 29; NoneNoneUnknown3iiiDiii
[12]Nonconsecutive case seriesVarious advanced101; 71; 30, placeboImproved weight maintenance or gain, 41 hydrazine sulfate treated vs. 17 placebo-treated patientsYes3iiiDiii
[18]Nonconsecutive case seriesGlioblastoma, astrocytoma, or meningiomaf465; 46; NoneImproved survival, patients with glioblastomaYesNoneg

No. = number.
aSee text for more details.
bNumber 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.
cThe 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.
dSurgery, chemotherapy, or radiation therapy given/allowed at the same time as hydrazine sulfate treatment.
eFor 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.
fThis study included six additional patients with benign brain tumors.
gInsufficient information given to permit a level of evidence analysis.

References

  1. Chlebowski RT, Bulcavage L, Grosvenor M, et al.: Hydrazine sulfate influence on nutritional status and survival in non-small-cell lung cancer. J Clin Oncol 8 (1): 9-15, 1990.  [PUBMED Abstract]

  2. Spremulli E, Wampler GL, Regelson W: Clinical study of hydrazine sulfate in advanced cancer patients. Cancer Chemother Pharmacol 3 (2): 121-4, 1979.  [PUBMED Abstract]

  3. Gold J: Use of hydrazine sulfate in terminal and preterminal cancer patients: results of investigational new drug (IND) study in 84 evaluable patients. Oncology 32 (1): 1-10, 1975.  [PUBMED Abstract]

  4. Kosty MP, Fleishman SB, Herndon JE 2nd, et al.: Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B. J Clin Oncol 12 (6): 1113-20, 1994.  [PUBMED Abstract]

  5. 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.  [PUBMED Abstract]

  6. 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.  [PUBMED Abstract]

  7. Filov VA, Gershanovich ML, Danova LA, et al.: Experience of the treatment with Sehydrin (Hydrazine Sulfate, HS) in the advanced cancer patients. Invest New Drugs 13 (1): 89-97, 1995.  [PUBMED Abstract]

  8. Lerner HJ, Regelson W: Clinical trial of hydrazine sulfate in solid tumors. Cancer Treat Rep 60 (7): 959-60, 1976.  [PUBMED Abstract]

  9. 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.  [PUBMED Abstract]

  10. Gershanovich ML, Danova LA, Ivin BA, et al.: Results of clinical study antitumor action of hydrazine sulfate. Nutr Cancer 3 (1): 7-12, 1981.  [PUBMED Abstract]

  11. Ochoa M Jr, Wittes RE, Krakoff IH: Trial of hydrazine sulfate (NSC-150014) in patients with cancer. Cancer Chemother Rep 59 (6): 1151-4, 1975 Nov-Dec.  [PUBMED Abstract]

  12. 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.  [PUBMED Abstract]

  13. 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.  [PUBMED Abstract]

  14. Filov VA, Gershanovich ML, Ivin BA, et al.: [Therapy of primary brain tumors with segidrin] Vopr Onkol 40 (7-12): 332-6, 1994.  [PUBMED Abstract]