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Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors
This study has been completed.

First Received on December 10, 1999.   Last Updated on July 31, 2010   History of Changes
Sponsor: Dana-Farber Cancer Institute
Collaborator: 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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Sarcosinamide Nitrosourea (SarCNU) in Patients With Solid Tumors

Resource links provided by NLM:


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

ClinicalTrials.gov Identifier: NCT00004079     History of Changes
Other Study ID Numbers: CDR0000067290, DFCI-99046, NCI-T98-0082
Study First Received: December 10, 1999
Last Updated: July 31, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasms
2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide
Carmustine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012