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Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors
This study has been completed.
First Received: December 10, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004079
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of sarcosinamide nitrosourea in treating patients who have metastatic or unresectable solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: SarCNU
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: N-Chlorothylnitrosourea sarcosinamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial of Sarcosinamide Nitrosourea (SarCNU) in Patients With Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of sarcosinamide nitrosourea in patients with metastatic or unresectable solid tumors.
  • Determine an appropriate oral dose of this drug for phase II study.
  • Determine the oral bioavailability of this drug in these patients.
  • Characterize the plasma pharmacokinetics of this drug in these patients.
  • Evaluate response to treatment with this drug in patients with measurable or evaluable disease.
  • Correlate, if possible, pharmacodynamics of this drug with toxicity and/or response in these patients.

OUTLINE: This is a dose-escalation study.

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.

Patients are followed at 4-5 weeks posttreatment.

PROJECTED ACCRUAL: A total of 21-46 patients will be accrued for this study within 12-18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic or unresectable solid tumors refractory to standard therapy or for which no curative or standard palliative therapy exists
  • No leukemia or primary CNS malignancies
  • CNS metastases allowed if:

    • No concurrent anticonvulsant therapy (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or felbamate)
    • Expected survival for at least 2 courses of therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min

Pulmonary:

  • DLCO at least 80% of predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled serious medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy and recovered
  • No prior nitrosourea or bleomycin

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks since major surgery and recovered

Other:

  • No concurrent enzyme-inducing anticonvulsants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004079

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Joseph Paul Eder, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067290, DFCI-99046, NCI-T98-0082
Study First Received: December 10, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004079     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

ClinicalTrials.gov processed this record on May 07, 2009