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Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies

NCT00629200 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-11-15

No results posted yet for this study

Summary

Primary Objective:

-To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies.

Secondary Objectives:

* To correlate the AUC of SSG with clinical toxicity and efficacy.
* To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal transduction pathways.
* To characterize the effects of SSG on PTPases SHP-1 and SHP-2.
* To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.

Conditions

Interventions

DRUG

Sodium Stibogluconate

400 mg/m\^2 IV daily on days 1-5.

DRUG

Interferon Alpha-2b

3x10\^6 units subcutaneously three times weekly

Sponsors & Collaborators

  • VioQuest Pharmaceuticals

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Aung Naing, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-13
Primary Completion
2010-02-10
Completion
2010-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629200 on ClinicalTrials.gov