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Home > "S" Clinical Trials Conditions > Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors  Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors
Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephEder, Study Chair, Dana-Farber/Harvard Cancer Center
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000067290; DFCI-99046,NCI-T98-0082
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004079
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors
2. EF5 in Treating Patients With Solid Tumors
3. Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
4. Creatine in Treating Patients With Cancer-Associated Weight Loss
5. MEN-10755 in Treating Patients With Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors
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