Evidence map›Paper›PMID 19532136›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2009

Phase I/II and phase II studies of targeted gene delivery in vivo: intravenous Rexin-G for chemotherapy-resistant sarcoma and osteosarcoma.

Sant P Chawla, Victoria S Chua, Lita Fernandez, Doris Quon, Andreh Saralou, William C Blackwelder, Frederick L Hall, Erlinda M Gordon

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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.

NCT04091295 availablenot on this map

BLESSED: Expanded Access for DNG64-CAR-V for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast

Typeexpanded_accessSponsorAveni FoundationConditionsPancreatic Cancer, Osteosarcoma, MPNST (Malignant Peripheral Nerve Sheath Tumor), ChondrosarcomaArmsDNG64-CAR-V
NCT04378244 phase1 / phase2withdrawnnot on this mapstarted 2022, after this paper: background citation

CORONA: A Phase 1/2 Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19

TypeinterventionalSponsorAveni FoundationRan2022 to 2024Enrolled0ConditionsCOVID-19, Cytokine Storm, Acute Respiratory Distress SyndromeArmsDeltaRex-G
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Nanomedicine in cancer therapy.Signal transduction and targeted therapy · 2023
    Review
  8. Article
  9. Review
  10. Viral vector-based gene therapies in the clinic.Bioengineering & translational medicine · 2022
    Review
  11. Article
  12. Review
  13. Review
  14. The vicissitudes of gene therapy.Bone & joint research · 2019
    Article
  15. Article
  16. Exploiting Oncogenic Drivers along theMolecular therapy oncolytics · 2018
    Review
  17. Article
  18. Review
  19. Article
  20. Review
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

8 authors at 2 institutions in 1 country.

Sant P ChawlaThe Sarcoma Oncology Center, Santa Monica, California, USA. santchawla@aol.com
Victoria S Chua
Lita Fernandez
Doris Quon
Andreh Saralou
William C Blackwelder
Frederick L Hall
Erlinda M Gordon
Sarcoma Oncology Center · USUniversity of Maryland, Baltimore · US

Funding

NCI NIH HHS CA 91108
6 · The paper itself

Abstract

Rexin-G, a pathotropic nanoparticle bearing a cytocidal cyclin G1 construct was tested in a phase I/II study for chemotherapy-resistant sarcomas and a phase II study for chemotherapy-resistant osteosarcoma. Twenty sarcoma patients and 22 osteosarcoma patients received escalating doses of Rexin-G intravenously from 8 x 10(11) to 24 x 10(11) colony forming units (cfu)/cycle. Treatment was continued if there was <or= grade 1 toxicity. No dose-limiting toxicity (DLT) was observed, and no vector DNA integration, replication-competent retrovirus (RCR) or vector-neutralizing antibodies were noted. In the phase I/II study, 3/6 patients had stable disease (SD) at the lowest dose; median progression-free survival (PFS) was 1.2 months, and overall survival (OS), 3.3 months. At higher doses, 10/14 patients had SD; median PFS was 3.7 months and median OS, 7.8 months. In this phase I/II study, a dose-response relationship with Rexin-G dosage was observed for progression-free and OS times (P = 0.02 and 0.005, respectively). In the phase II study, 10/17 evaluable patients had SD, median PFS was >or=3 months and median OS, 6.9 months. These studies suggest that Rexin-G is safe, may help control tumor growth, and may possibly improve survival in chemotherapy-resistant sarcoma and osteosarcoma.

Indexed as

AdolescentAdultAgedCyclin GCyclin G1CyclinsDrug Resistance, NeoplasmFemaleGenetic TherapyGenetic VectorsHumansMaleMiddle AgedOsteosarcomaRetroviridaeSarcomaCCNG1 protein, humanCyclin GCyclin G1Cyclins

Identifiers

PMID19532136
PMCPMC2835268
OpenAlexW2066159416

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.