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NCT00656123 · ClinicalTrials.gov registry record · Phase 1
Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00656123: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00656123 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656123, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide
Primary Outcome
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v3) will be counted only once for a given subject.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL Colon GVAX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2008-03 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT00656123 record still lists
NCT00656123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which cyclophosphamide is the first listed.
NCT00656123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656123 about?
NCT00656123 is a clinical study titled "Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer". The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide
What is the current status of trial NCT00656123?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2008-03. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00656123?
The interventions under investigation include: cyclophosphamide (DRUG), Colon GVAX (BIOLOGICAL).
Who is sponsoring clinical trial NCT00656123?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656123's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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