NCT00003766

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine followed by surgery in treating patients who have solid tumors that can be removed during surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 1999

Typical duration 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

October 1, 1999

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

February 20, 2004

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

2.1 years

First QC Date

November 1, 1999

Last Update Submit

March 5, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Determine minimal dose

    Determine minimal dose of 06-benzylguanine (06-BG) at which there is a depletion of tumor 06-BG DNA alkyltransferase activity to \<10 fmol/mg protein

    2 years

Study Arms (1)

Arm A

EXPERIMENTAL

06-benzylguanine (100mg/m2 16 hrs before anticipated tumor tissue removal)

Drug: O6-benzylguanine

Interventions

O6-benzylguanineDRUG
Arm A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed surgically resectable solid tumor PATIENT CHARACTERISTICS: Age: Not specified Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Medically cleared for surgery No active medical or psychiatric disease that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Interventions

O(6)-benzylguanine

Study Officials

  • Mark J. Ratain, MD

    University of Chicago

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 20, 2004

Study Start

October 1, 1999

Primary Completion

November 1, 2001

Study Completion

November 1, 2001

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

US(1)