NCT00004079

Brief Summary

Phase I trial to study the effectiveness of sarcosinamide nitrosourea in treating patients who have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Trial Health

80
On Track

Trial Health Score

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

Enrollment
46

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

August 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

6.1 years

First QC Date

December 10, 1999

Last Update Submit

January 31, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • MTD

    28 days

  • Pharmacokinetics: plasma concentration-time profiles of SarCNU

    Analyzed by nonlinear least squares regression using WinNonlin (Scientific Consulting, Inc.). Final values of the iterated parameters in the best-fit equations describing the plasma profiles will be used to calculate all pharmacokinetic terms according to standard equations. Mean values of the pharmacokinetic parameters will be calculated at each dose and subject to appropriate statistical tests for the existence of dose-dependent trends.

    Days 1 and 9 of course 1: 5, 15, 20, 30, and 45 min; 1, 2, 3, 4, and 6 hr

Study Arms (1)

Treatment (SarCNU)

EXPERIMENTAL

Patients receive oral sarcosinamide nitrosourea (SarCNU) on days 1, 5, and 9. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SarCNU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Drug: SarCNUOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

SarCNUDRUG

Given PO

Treatment (SarCNU)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (SarCNU)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (SarCNU)

Eligibility Criteria

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

You may qualify if:

  • Histologically documented malignancy, which is either metastatic or inoperable, for which there is no known curative or standard palliative therapy, or all standard therapeutic approaches have failed
  • Patients with leukemia or primary CNS malignancies are excluded; patients with metastatic disease to the CNS, who are not receiving anticonvulsants, including phenytoin, carbamazepine, phenobarbital, primidone, and felbamate, and who have reasonable expectation of surviving long enough to receive two cycles of therapy, are eligible
  • Life expectancy of 2 months or longer
  • ECOG performance status of 0-2
  • Pretreatment laboratory data, obtained within 14 days of study entry, must meet the following criteria:
  • ANC \>= 1,500 /mm\^3
  • Platelets \>= 100,000 /mm\^3
  • SGOT =\< 2.5-times upper limit of normal
  • SGPT =\< 2.5-times upper limit of normal
  • Total bilirubin =\< upper limit of normal
  • Creatinine =\< 1.5 mg/dl
  • Creatinine CL \>= 60 ml/min (measured 24hr) if creatinine \> 1.5 mg/dl
  • DLCO \>= 80% predicted
  • At least 4 weeks since last receiving radiotherapy or chemotherapy and complete recovery from previous treatment related toxicity
  • No prior treatment with a nitrosourea or with bleomycin
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

Study Officials

  • Joseph Eder

    Dana-Farber Cancer Institute

    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

December 10, 1999

First Posted

April 9, 2003

Study Start

August 1, 1999

Primary Completion

September 1, 2005

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

US(1)