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Studies of Hydrazine Sulfate in Which
Therapeutic Benefit Was Assesseda
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Reference Citation(s)
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Type of Study
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Type of Cancer
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No. of Patients: Enrolled; Treated; Controlb
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Strongest Benefit Reportedc
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Concurrent Therapyd
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Level
of Evidence Scoree
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| [1] |
Randomized
clinical trial |
Advanced
nonsmall
cell lung |
65; 32; 33, placebo |
None |
Yes |
1iA |
| [2] |
Nonconsecutive
case series
|
Various
advanced |
25; 25; None |
Slight
regression
of some
metastatic
lesions,
1 patient
with
melanoma |
No |
3iiiDiii |
| [3] |
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 |
| [5] |
Randomized
clinical trial |
Advanced
colorectal |
128; 63; 64, placebo |
None |
No |
1iA |
| [6] |
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 |
| [8] |
Nonconsecutive
case series |
Various
advanced |
25; 25; None |
None |
No |
3iiiDiii |
| [11] |
Nonconsecutive
case series |
Various
advanced |
32; 29; None |
None |
Unknown |
3iiiDiii |
| [12] |
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 |
| [18] |
Nonconsecutive
case series |
Glioblastoma,
astrocytoma, or
meningiomaf |
465; 46; None |
Improved
survival,
patients
with
glioblastoma |
Yes |
Noneg |
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No. = number.
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aSee text for more details.
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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.
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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.
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dSurgery, chemotherapy, or radiation therapy given/allowed at the same
time as hydrazine sulfate treatment.
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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.
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fThis study included six additional patients with benign brain tumors.
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gInsufficient information given to permit a level of evidence analysis.
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References
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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]
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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.
[PUBMED Abstract]
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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]
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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]
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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.
[PUBMED Abstract]
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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]
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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]
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Lerner HJ, Regelson W: Clinical trial of hydrazine sulfate in solid tumors. Cancer Treat Rep 60 (7): 959-60, 1976.
[PUBMED Abstract]
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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.
[PUBMED Abstract]
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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]
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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]
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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.
[PUBMED Abstract]
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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]
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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]
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