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Home > "3" Clinical Trials Conditions > 3-AP in Treating Patients With Advanced Cancer  3-AP in Treating Patients With Advanced Cancer
3-AP in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Vion Pharmaceuticals ,
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 3-AP in treating patients who have advanced cancer.
Details: OBJECTIVES: I. Determine the safety, tolerability, and toxicity of 3-AP in patients with advanced malignancies. II. Determine the maximum tolerated dose and recommended phase II dose of this treatment in these patients. III. Determine the pharmacokinetic parameters of this treatment in these patients. IV. Determine the tumor response in these patients treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients receive 3-AP IV continuously over 96 hours. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response receive treatment for 1 course past the course in which the complete response was documented; patients with partial response may receive treatment for up to 1 year; and patients with stable disease may receive treatment for up to 6 months. During the accelerated phase of the study, cohorts of 1 patient each receive escalating doses of 3-AP until one patient experiences dose limiting toxicity (DLT) or 2 different patients experience grade 2 toxicity during any course. When the accelerated phase ends, cohorts of 3-6 patients receive escalating doses of 3-AP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. PROJECTED ACCRUAL: Approximately 21 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced or metastatic malignancy; Failed one or more prior standard therapies or considered unlikely to respond to any currently available therapy - Measurable or evaluable disease - No active, untreated CNS metastases (stable for at least 2 months and no evidence of new CNS metastases) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered; No persistent chronic toxicity from prior chemotherapy greater than grade 1 - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy; Concurrent radiotherapy to single site of progressive disease allowed during first course of study treatment - Surgery: Not specified - Other: At least 3 weeks since any prior treatment for malignancy and recovered; No other concurrent investigational drug --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Greater than 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL (transfusion allowed); No bleeding disorder (except occult blood for gastrointestinal cancers) - Hepatic: Bilirubin no greater than 2.0 mg/dL; ALT, AST, and alkaline phosphatase no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN with liver metastases); PT and PTT no greater than 1.5 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No active heart disease; No myocardial infarction within the past 3 months; No symptomatic coronary artery disease or heart block; No uncontrolled congestive heart failure - Pulmonary: No moderate to severe compromise of pulmonary function - Other: No active infection; No mental deficits and/or psychiatric history that would preclude study; No other concurrent life threatening illness; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 18 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: CDR0000068067; VION-CLI-009,NCI-V00-1598,AECM-12000041110
Study Start Date: May 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006218
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
2. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
3. BMS-214662 in Treating Patients With Solid Tumors
4. Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer
5. S-3304 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
3-AP in Treating Patients With Advanced Cancer
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