NCT00103220

Brief Summary

This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

February 7, 2005

Last Update Submit

December 10, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Recommended phase 2 dose of SJG-136

    Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.

    Day 28

Study Arms (1)

Treatment (SJG-136)

EXPERIMENTAL

Patients receive SJG-136 IV over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: SJG-136

Interventions

SJG-136DRUG

Given IV

Treatment (SJG-136)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed solid tumor
  • Advanced disease, defined as metastatic or unresectable disease
  • Measurable indicator lesions
  • Standard curative or palliative measures do not exist or are no longer effective
  • Previously treated CNS metastases allowed provided patient has completed local therapy AND corticosteroids have been discontinued for at least 4 weeks
  • No known leptomeningeal metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 1.0 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine \< 1.4 mg/dL
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

1,1'-((propane-1,3-diyl)dioxy)bis(7-methoxy-2-methylidene-1,2,3,10,11,11a-hexahydro-5H-pyrrolo(2,1-c)(1,4)benzodiazepin-5,11-dione)

Study Officials

  • Naiyer Rizvi

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2005

First Posted

February 8, 2005

Study Start

November 1, 2004

Primary Completion

February 1, 2007

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

US(1)