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NCT00337194 · ClinicalTrials.gov registry record · Phase 2

SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

A Phase 2 study of Recurrent Adult Hodgkin Lymphoma and Adult Lymphocyte Depletion Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT00337194: Completed Phase 2 study of Recurrent Adult Hodgkin Lymphoma and Adult Lymphocyte Depletion Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).

NCT00337194 is a Phase 2 study of Recurrent Adult Hodgkin Lymphoma and Adult Lymphocyte Depletion Hodgkin Lymphoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, roughly in line with the 28-participant average among 4 other Recurrent Adult Hodgkin Lymphoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00337194, a Phase 2 study of Recurrent Adult Hodgkin Lymphoma and Adult Lymphocyte Depletion Hodgkin Lymphoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.

Primary Outcome

The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): \>= 50% reduction in sum of the product of diameters of indicator lesions.

Interventions

  • OTHER placebo
  • DRUG pegylated liposomal doxorubicin hydrochloride
  • DRUG gemcitabine hydrochloride
  • DRUG vinorelbine tartrate
  • BIOLOGICAL monoclonal antibody SGN-30

Study Locations (1)

Illinois

  • Cancer and Leukemia Group B - Chicago

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2006-04
Est. Completion 2014-10
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00337194 record still lists

NCT00337194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, roughly in line with the 28-participant average among 4 other Recurrent Adult Hodgkin Lymphoma trials with a reported enrollment target.

The record links to 5 conditions, with Recurrent Adult Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which placebo is the first listed.

NCT00337194 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT00337194 about?

NCT00337194 is a clinical study titled "SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma". This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodi...

What is the current status of trial NCT00337194?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2006-04. Estimated completion is 2014-10.

What conditions does trial NCT00337194 study?

This clinical trial studies the following conditions: Recurrent Adult Hodgkin Lymphoma, Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma.

What interventions are being tested in trial NCT00337194?

The interventions under investigation include: placebo (OTHER), pegylated liposomal doxorubicin hydrochloride (DRUG), gemcitabine hydrochloride (DRUG), vinorelbine tartrate (DRUG), monoclonal antibody SGN-30 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00337194?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00337194 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00337194, the US trial registry maintained by the National Library of Medicine. NCT00337194 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.