Evidence map›Paper›PMID 14739661›Full record

Trial reportInvestigational new drugs2004

Phase I trial of the polyamine analog N1,N14-diethylhomospermine (DEHSPM) in patients with advanced solid tumors.

George Wilding, David King, Kendra Tutsch, Marcia Pomplun, Chris Feierabend, Dona Alberti, Rhoda Arzoomanian

Abstract readClinical TrialClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Subcutaneous Toxicity of Agmatine in Rats.Turkish journal of pharmaceutical sciences · 2017
    Article
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

George WildingUniversity of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, USA.
David King
Kendra Tutsch
Marcia Pomplun
Chris Feierabend
Dona Alberti
Rhoda Arzoomanian
University of Wisconsin System · US

Funding

PHASE I TRIALS OF ANTICANCER AGENTSU01CA062491 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI LIU, GLENN · 1994 to 2013
$7.6M
NCI NIH HHS U01 CA062491NCI NIH HHS U01CA62491
6 · The paper itself

Abstract

backgroundThis phase I study was conducted to determine maximal tolerated dose (MTD) and dose-limiting toxicities (DLT) in patients with advanced solid tumors treated with the polyamine analog N1, N14-diethylhomospermine (DEHSPM).

methodsPatients were treated with DEHSPM administered as a subcutaneous (SC) injection daily for five consecutive days repeated every 4 weeks. Three dose levels were examined starting at 12.5 mg/m2/day, escalating to 37.5 mg/m2/day.

resultsA total of 15 patients were enrolled. Dose limiting toxicities (grade 3 or 4) included nausea, vomiting, constipation, ileus, elevations of aspartate aminotransferase (AST) and alkaline phosphatase, hyperbilirubinemia, and ventricular bigeminy.

conclusionDEHSPM given as a SC injection is overall well tolerated at lower doses, but significant toxicities were observed at the 37.5mg/m2/day dose level. MTD was established at 25 mg/m2/day but further investigation with this study drug is not recommended secondary to the potential for neurotoxicities and hepatic damage as a result of cumulative doses.

Indexed as

AgedDose-Response Relationship, DrugDrug Administration ScheduleFemaleGastrointestinal DiseasesHumansMaleMiddle AgedNeoplasmsPolyaminesSpermineN(1),N(14)-bis(ethyl)homosperminePolyaminesSpermine

Identifiers

PMID14739661
OpenAlexW2092865014

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.